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@#Introduction: Amlodipine besylate is a calcium channel blocker indicated for hypertension and angina. It is described as slightly soluble in water and due to its limited solubility, it may result in poor bioavailability. The aim of this study is to enhance the solubility of amlodipine besylate using solvent evaporation method and microemulsion technique and to compare the two methods. Method: Solid dispersions (SD) of amlodipine besylate were developed by employing solvent evaporation method. PEG6000 was the polymer of choice and different drug:polymer ratios were used. Evaluation of the prepared SDs include solubility studies, dissolution studies and scanning electron microscopy (SEM). As for the microemulsion technique, microemulsions were prepared by phase titration method and the optimized microemulsion formulation was then characterized for solubility studies and dissolution studies. Results: SD3 with drug:polymer ratio of 1:4 achieved the highest solubility which was 96.97 mg/ml ± 0.92 whereas the solubility of the optimized microemulsion was found to be 112.54 mg/ml ± 0.92. In solvent evaporation method, as the drug:polymer ratio increases, the solubility and dissolution rate of SDs increases. Conclusion: The two methods had significantly enhance the solubility of amlodipine besylate however the microemulsion technique showed better solubility profile.
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Objective: To develop and validate a simple and accurate cost-effective titrimetric method according to International Conference Harmonization (ICH) guidelines for acetic acid content in Amlodipine Besylate. Methods: The titration based on general acid-base reaction to form water and salt. Sodium hydroxide act as a strong base and titrated against weak acid (acetic acid). Phenolphthalein used as an indicator and colorless to pink is the endpoint. Sodium hydroxide is standardized with primary standard potassium hydrogen phthalate. Results: The method was linear in the range of 0.75 to 30.25 μg/ml with a correlation coefficient 0.9999. Limit of detection (LOD) and limit of quantitation (LOQ) value were found to be 0.61 and 1.85 μg/ml, respectively. The percentage recovery (98.20–99.97%) and percentage relative standard deviation (%RSD) is less than 2% within the acceptable limit of ICH guidelines. The robustness and ruggedness results were excellent. Method is accurate and precise, no interference from excipients. Conclusion: A new analytical titrimetric method was developed and validated as per ICH guidelines for the determination of acetic acid content in amlodipine. This proposed method applied for routine analysis of acetic acid content in bulk and pharmaceutical formulations of amlodipine besylate.
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Objective: To discuss the diagnosis and treatment process of abnormally elevated blood pressure in the patient treated with rifampicin and antihypertensive drugs, to analyze the interaction between rifampicin and antihypertensive drugs, and to improve the clinicians' understanding of the administration in the patients. Methods: The clinical materials of a patient treated with rifampicin and antihypertensive drugs were collected, and the relationship between the blood pressure change and drug was analyzed. The changes of concentrations of dihydropyridine-based calcium antagonists after administration of rifampin were observed and the relative literatures were reviewed. Results: A 58-year-old man with coughing and coughing for 1 month was admitted to hospital. The patient was definitely diagnosed as tuberculosis and hypertension before admission; the patient was treated with rifampicin, isoniazid, ethambutol, pyrazinamide, and felodipine together. The original treatment plan was continued and the blood pressure of the patient was monitored. On the 9th day of anti-tuberculosis treatment, the patient developed dizziness, chest tightness, and severe fluctuations in blood pressure. Then rifampicin was stopped and antihypertensive drugs were adjusted. At the beginning of blood pressure fluctuation of the patient, the combination of angiotensin-converting enzyme inhibitors and the increasing dose of dihydropyridine-based calcium antagonists did not control the blood pressure. The blood pressure began to decrease significantly at 36 h after rifampin was stopped. On the 18th day of anti-tuberculosis treatment, the original antihypertensive plan was restored and the blood pressure remained stable. Conclusion: Rifampicin can sometimes significantly reduce the effect iveness of antihypertensive drugs (such as dihydropyridine calcium antagonists), and the clinicians should pay attention to it.
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Objective To compare three different anti-hypertension therapeutic projects by pharmacoeconomic evaluation and to find out the best therapeutic project.Methods Retrospective study was used.120 patients with hypertension were ran-domly assigned to group A(fosinopril sodium),group B(valsartan),group C(amlodipine besylate tablet),the therapeutic effects were observed and were evaluated by cost minimization analysis.Results The total efficiency of A,B,C group were 90·7%, 92·3%,92.1%(P>0.05)respectively.The incidence of adverse reaction were 16.7%,7.7%,13.2%(P>0.05)respective-ly.The costs were 287.3 yuan,378.7 yuan and 320.4 yuan respectively.Conclution The effectiveness of the three groups was similar.In terms of pharmacoeconomics,group A was the best therapeutic project.
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Objective To study and analyze the effect of amlodipine besylate and amlodipine besylate in the treatment of hypertension. Methods 100 patients with hypertension treated in our hospital from January 2015 to December 2016 were selected and randomly divided into two groups, the control group and the experimental group, with 50 patients in each group. The control group was treated with amlodipine besylate, and the patients in the experimental group were treated with amlodipine besylate and amlodipine besylate. The therapeutic effects of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, the experimental group of 50 cases, the total effective number of 44 cases, 6 patients invalid, the total effective rate was 88%. In the control group of 50 cases, the total effective number was 37 cases, 13 cases were invalid, the total effective rate was 74%. The treatment effect of the experimental group was significantly higher than that of the control group, with statistical difference (P<0.05). There were 5 cases of adverse reactions in the experimental group, 3 patients had facial flushing, and 2 patients suffered from pain. The incidence was 10%. The number of adverse reactions in the control group was 12 cases, ankle edema occurred in 5 patients, and headache occurred in 7 patients, with a rate of 24%. The rate of adverse reactions in the control group was significantly higher than that in the experimental group, with statistical difference (P<0.05). Conclusion Amlodipine and Levamlodipine besylate in treatment of hypertension can improve the treatment efficiency to a great extent, high safety, low probability of adverse reactions, with further clinical promotion and application significance.
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OBJECTIVE:To observe the clinical efficacy and safety of amlodipine besylate combined with lisinopril and hydro-chlorothiazide,atorvastatin in the treatment of severe primary hypertension complicating with carotid atherosclerosis. METHODS:90 patients with severe primary hypertension complicating with carotid atherosclerosis were divided into control group (45 cases) and observation group(45 cases)according to random lottery form. Both groups were given Atorvastatin calcium tablet 20 mg/time orally,qd;control group was additionally given Amlodipine besylate tablet 5 mg/time orally,qd;observation group was additional-ly given Lisinopril and hydrochlorothiazide tablet 10 mg/time orally,qd,on the basis of control group. Both groups were treated for 8 weeks. Clinical efficacies of 2 groups were compared as well as blood pressure level,IMT,PV of carotid atherosclerosis, hs-CRP,TNF-α before and after treatment. The occurrence of ADR was recorded. RESULTS:Total response rate of observation group was significantly higher than that of control group,with statistical significance (P0.05). After treatment,the levels of SBP,DBP, IMT,PV,hs-CRP and TNF-α level in 2 groups were significantly lower than before;the observation group was significantly lower than the control group,with statistical significance (P0.05). CONCLUSIONS:Amlodipine besylate combined with lisinopril and hydrochlorothiazide,atorvastatin in the treatment of primary hypertension complicating with carotid atherosclerosis can effectively control the blood pressure level, delay the progression process of carotid atherosclerosis,reduce the inflammatory reaction degree,but dose not increase the occur-rence of ADR with good safety.
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Objective To analyse clinical effects of Juming Jiangya pill combined with amlodipine besylate in treatment of essential hypertension.Methods 126 patients with essential hypertension from August 2015 to October 2016 were grouped two groups and each with 63 cases.The control group were treated with amlodipine besylate,and observation group was treated with Juming Jiangya pill.The effect of 2 groups of antihypertensive treatment, the influence on related factors and the safety were analyzed.Results (After treatment,total effective rate of observation group was 95.24%,higher than that of control group 80.95%(P<0.05).(After treatment,SBP and DBP level of observation group[were(128.5±6.3),(78.4±5.2)mmHg],lower than that of control group[(140.2±7.5),(88.7±5.5)mmHg](all P<0.05).③After treatment,plasma NO and serum ET level of observation group were[(70.16±5.51)μmol/L,(66.24±5.40)ng/L],better than that of control group[(64.16±5.33)μmol/L,(73.05±5.68)ng/L)](all P<0.05).④During treatment,proportion of adverse reactions of control group was 11.11%,higher than that of observation group 4.76%,difference was not statistically significant.Conclusion Juming Jiangya pill combined with amlodipine besylate have better curative effect and medication safety.
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Objective:To establish a method for the determination of atorvastatin and amlodipine in compound atorvastatin calcium and amlodipine besylate tablets. Methods:The determination was performed on a Gemini-NX C18 column (250 mm × 4. 6 mm, 5μm) with the mobile phase consisting of 20 mmol·L-1 potassium dihydrogen phosphate solution ( adjusting pH to 4 with phosphoric acid)-acetonitrile-methanol (30 ∶10 ∶60) at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 240 nm and the column tem-perature was 30℃. The injection volume was 20μl. Results:The linear range of atorvastatine and amlodipine was 0. 4-40. 0μg·ml-1 and 0. 2-20. 0 μg·ml-1, respectively. The mean recovery of atorvastatin and amlodipine was 100. 6% and 99. 7%, and RSD was 0. 92% and 0. 85% (n=9), respectively. Conclusion:The method is special, stable and reliable, and can be used for the content determination of compound atorvastatin calcium and amlodipine besylate tablets.
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OBJECTIVE:To observe the efficacy and safety of amlodipine besylate combined with Xinkeshu in the treatment of hypertension. METHODS:100 patients with hypertension were randomly divided into control group (50 cases) and observation group(50 cases). Control group was orally given one Amlodipine besylate tablet,once a day;observation group was additionally given 4 Xinkeshu tablets,3 times a day. The treatment course was 8 weeks. Clinical efficacy,systolic blood pressure(SBP)and di-astolic blood pressure(DBP)before and after treatment in 2 groups were observed,the incidence of adverse reactions was record-ed. RESULTS:The total effective rate in observation group was significantly higher than control group,the incidence of adverse re-actions was significantly lower than control group,the differences were statistically significant (P0.05). After treatment,the SBP and DBP in 2 groups were significantly lower than before,the differences were statistically significant(P0.05). CONCLUSIONS:The efficacy of amlodipine besylate combined with Xinkeshu is superior to amlo-dipine besylate alone in the treatment of hypertension,with better safety.
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A simple, accurate and reproducible spectrophotometric methods have been developed for the simultaneous estimation of Telmisartan (TEL) and Amlodipine Besylate (AML) in combined tablet dosage forms. The method involves determination using the simultaneous equation method, the sampling wavelengths selected are ‘TLM’ = 297nm.and ‘AML’ =238nm., over the concentration ranges of 8-48µg/ml for ‘TEL’ and 1-6 µg/ml for ‘AML’ respectively. The method was validated for linearity, accuracy, precision, robustness and application for assay as per ICH guidelines. The proposed method is simple, economical, accurate and precise, and could be successfully employed in routine quality control for the simultaneous analysis of Telmisartan (TEL) and Amlodipine Besylate (AML).
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OBJECTIVES: Single-pill combination therapy (amlodipine/atorvastatin) might be more effective than double-pill therapy (amlodipine+atorvastatin) in patients with diabetes and concomitant hypertension requiring statin therapy. We compared the cost-effectiveness of a single-pill with that of double-pill for control of low density lipoprotein cholesterol (LDL-C) levels, with the ultimate goal of cardiovascular disease prevention, in these patients using a cost-effectiveness analysis model that considered medication adherence. METHODS: Effectiveness was defined as the percentage (%) attainment of target LDL-C levels ( or =80% proportion of days covered). A systematic review of the literature was conducted to determine the proportion of patients who were adherent and target goal attainment based on adherence level. The annual medication costs were based on the adherence levels for each regimen. The average cost-effectiveness ratio (ACER) was calculated as the cost per % attainment of the target LDL-C level. RESULTS: The ACER for the single-pill regimen was lower than for the double-pill regimen (4,123 vs. 6,062 Korean won per 1% achievement of target goal). Compared with the double-pill, the medication costs were approximately 32% lower with the single-pill. CONCLUSION: A single-pill for reductions in LDL-C is cost-effective compared with double-pill in hypertensive patients with type 2 diabetes.
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Humans , Acer , Amlodipine , Cardiovascular Diseases , Cholesterol, LDL , Compliance , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hypertension , Korea , Lipoproteins , Medication Adherence , AtorvastatinABSTRACT
Objective] To analyse the effect of combining acupuncture of soothing liver, smooth liver and nourishing kidney with Amlodipine Besylate Tablets on light, medium hyperactivity of liver-YANG syndrome hypertension. [Methods] From January 2013 to January 2014, we collected 60 patients with hyperactivity of liver-YANG syndrome meeting the criterion. 30 patients in control group, taking Amlodipine Besylate Tablets, 14 male, 16 female, average age was 62.0 years old(54~72 years old); 30 cases in treatment group, on the basis of control group using soothing liver, smooth liver and nourishing kidney acupuncture, 13 males, 17 females, average age was 61.5 years old(53~73 years old). Patients were collected 24 hours ambulatory blood pressure, anxiety, TCM syndrome integral before and after treatment. [Results] After treatment, control group and the treatment group of ambulatory blood pressure, anxiety and TCM syndrome integral was significantly improved, the differences were statistically significant( P<0.05). In treatment group, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure, nighttime diastolic blood pressure, 24h diastolic blood pressure and 24h systolic blood pressure were decreased significantly lower than the control group, and anxiety value, TCM syndrome integral was also improved better than control group(P<0.05). [Conclusion] Soothing liver, smooth liver and nourishing kidney acupuncture combined with oral drug can effectively control blood pressure for hyperactivity of liver-YANG syndrome hypertension patients; meantime it also can significantly relieve the TCM syndrome and anxiety symptom.
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OBJECTIVE:To observe therapeutic efficacy and safety of amlodipine besylate combined with valsartan in the treatment of hypertension. METHODS:158 patients with hypertension were randomly divided into control group (n=78) and treatment group (n=80). Control group was treated with amlodipine besylate,2.5 mg/time,3 times/d;treatment group was addi-tionally treated with valsartan,80 mg/time,once a day. A treatment course lasted for 4 weeks,and both received 5 courses. Clini-cal efficacy,blood pressure,plasma concentrations of ET-1,NT-proBNP and Ang Ⅱ were compared between 2 groups. RE-SULTS:The compliance rates of treatment group after 4,8,12,16,20 weeks were higher than that of the control group(P0.05). CONCLUSIONS:Amlodipine besylate combined with valsartan can effectively control the blood pres-sure in patients with hypertension,which may be related to the inhibition of ET-1,NT-proBNP and AngⅡ.
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Objective:To establish an HPLC method for the simultaneous determination of telmisartan and amlodipine besylate in tablets. Methods:The isocratic separation was achieved on a Phenomenex C18 column (150 mm × 4. 6 mm, 5 μm) with the mobile phase composed of 50 mmol·L-1 sodium dihydrogen phosphate buffer (pH 6. 0, 0. 5% triethylamine)-acetonitrile (40:60, v/v). The flow rate was 1. 0 ml·min-1 , the detection wavelength was 254 nm, the column temperature was 30℃ and the sample size was 20μl. Results:Telmisartan could be well separated from amlodipine besylate under the conditions mentioned above. The linearity be-tween the peak area and the concentration was obtained within the range of 4. 0-80. 0 μg·ml-1(r=0. 999 9) for telmisartan and 1. 0-20. 0 μg·ml-1(r=0. 999 9) for amlodipine besylate. The mean recovery of telmisartan and amlodipine besylate was 99. 90% and 100. 52%, and RSD was 0. 74% and 1. 48%, respectively (n=9). Conclusion:The method is specific, stable and accurate in the determination of compound telmisartan tablets.
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Objective:To establish an HPLC method for the simultaneous determination of olmesartan medoxomile, amlodipine be-sylate and hydrochlorothiazide in compound olmesartan medoxomile tablets. Methods:The desired chromatographic separation was a-chieved on a Phenomenex C18 (250 mm × 4. 6 mm, 5μm) column. With gradient elution, the optimized mobile phase consisted of ace-tonitrile as solvent A, and 50 mmol·L-1 potassium dihydrogen phosphate buffer (pH 3. 0, containing 0. 05% triethylamine) as sol-vent B. The flow rate was set at 1. 0 ml·min-1 , the column temperature was 30 ℃, the UV detection was carried out at 236 nm and the sample size was 20μl. Results:The compounds were separated well, the linearity between the peak area and the concentration was observed within the range of 4. 0-80. 0 mg·L-1(r=0. 999 9)for olmesartan medoxomile, 1. 0-20. 0 mg·L-1(r=0. 999 9)for amlo-dipine besylate and 1. 25-25. 0 mg·L-1(r=0. 999 9)for hydrochlorothiazide. The average recovery of olmesartan medoxomile, amlo-dipine besylate and hydrochlorothiazide was 99. 1%(RSD=1. 31%, n=9), 100. 3%(RSD=1. 21%, n=9) and 100. 2%(RSD=1. 06%, n=9), respectively. Conclusion:The method is specific and stable in the determination of olmesartan medoxomile, amlo-dipine besylate and hydrochlorothiazide in the tablets.
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OBJECTIVE:To observe the clinical efficacy and safety of candesartan combined with amlodipine besylate in the treatment of elderly hypertension. METHODS:Totally 156 elderly patients with hypertension were randomly divided into control group and observation group. Patients in control group were orally given Amlodipine besylate tablets 5 mg in the morning,once a day. Patients in observation group were orally given Candesartan tablets 8 mg based on the treatment of control group,once a day. The course of both was 8 weeks. The clinical data was observed,including clinical efficacy,systolic blood pressure(SBP)and dia-stolic blood pressure(DBP)before and after treatment,fasting blood glucose(FPG),insulin resistance index(HOMA-IR),24 h urinary albumin total(mAlb),serum creatinine(SCr)and the incidence of adverse reactions. RESULTS:The total effective rate in observation group was significantly higher than control group;the HOMA-IR,mAlb and SCr in observation group were significant-ly lower than control group,with significant difference(P0.05). There were no obvious adverse reactions during treatment. CONCLUSIONS:Candesartan combined with amlodipine besylate has better efficacy than only amlodipine besylate in the treatment of elderly hypertension,with similar safety.
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The dissolution process is considered an important in vitro tool to evaluate product quality and drug release behavior. Single dissolution methods for the analysis of combined dosage forms are preferred to simplify quality control testing. The objective of the present work was to develop and validate a single dissolution test for a telmisartan (TEL) and amlodipine besylate (AML) combined tablet dosage form. The sink conditions, stability and specificity of both drugs in different dissolution media were tested to choose a discriminatory dissolution method, which uses an USP type-II apparatus with a paddle rotating at 75 rpm, with 900 mL of simulated gastric fluid (SGF without enzymes) as the dissolution medium. This dissolution methodology provided good dissolution profiles for both TEL and AML and was able to discriminate changes in the composition and manufacturing process. To quantify both drugs simultaneously, a synchronous first derivative spectrofluorimetric method was developed and validated. Drug release was analyzed by a fluorimetric method at 458 nm and 675 nm for AML and TEL, respectively. The dissolution method was validated as per ICH guidance.
O processo de dissolução é considerado como uma importante ferramenta in vitro para avaliar a qualidade do produto e o comportamento de liberação do fármaco. Prefere-se um ensaio único de dissolução para formas farmacêuticas contendo associação de fármacos pela simplificação dos testes de controle de qualidade. O objetivo do presente trabalho foi desenvolver e validar um teste de dissolução único para forma farmacêutica comprimidos contendo telmisartana (TEL) e besilato de anlodipino (AML) associados. Condições "sink", estabilidade e especificidade de ambos os fármacos nos diferentes meios de dissolução foram avaliadas para selecionar um método de dissolução discriminatório, que utiliza um aparato do tipo II da USP, com pás girando a 75 rpm e 900 mL de fluido gástrico simulado (SGF sem enzima) como o meio de dissolução. Estas condições proporcionaram bons perfis de dissolução para ambos, TEL e AML, sendo capaz de discriminar as mudanças na composição e processo de fabricação. Para quantificar os dois fármacos simultaneamente, um método de fluorescência derivada sincronizado foi desenvolvido e validado. A quantidade de fármaco liberado foi analisada pelo método fluorimétrico em 458 e 675 nm para a AML e TEL, respectivamente. O método de dissolução foi validado de acordo com a orientação da ICH.
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Spectrometry, Fluorescence/methods , Antihypertensive Agents , Quality Control , Dosage Forms , Dissolution/classificationABSTRACT
The aim of this study was to evaluate the effect of dissolution medium, rotation speed and compaction pressure on the intrinsic dissolution rate (IDR) of the antihypertensive drug amlodipine besylate, using the rotating disk method. Accordingly, a fractional factorial design (33-1) was used, employing dissolution media (water, phosphate buffer pH 6.8 and HCl 0.1 M), rotation speed (50, 75 and 100 rpm), and compaction pressure (1000, 1500 and 2000 psi) as independent variables. The assays were randomized and statistically compared using the Statistica(r) 11 software program. Significance testing (ANOVA) indicated that the dissolution medium had a considerable impact on the IDR of amlodipine besylate. Analysis of the linear and quadratic components of the variables led to the proposition of a mathematical model that describes the IDR as a function of the parameters studied. Conversely, the levels of compaction pressure and rotation speed employed during experimental planning were less relevant, especially when the assay was conducted in the HCl 0.1 M medium.
A finalidade do presente trabalho foi avaliar o efeito do meio de dissolução, velocidade de rotação e pressão de compactação na velocidade de dissolução intrínseca (VDI) do fármaco anti-hipertensivo besilato de anlodipino, usando o método do disco rotativo. Dessa forma, foi utilizado um planejamento experimental do tipo fatorial facionado (33-1) utilizando como variáveis independentes o meio de dissolução (água, HCl 0,1M e tampão fosfato pH 6,8), velocidade de rotação (50, 75 e 100 rpm) e pressão de compactação do fármaco (1000, 1500 e 2000 psi). Os ensaios foram randomizados e comparados estatisticamente pelo software Statistica(r) 11. A análise de variância (ANOVA) indicou que o meio de dissolução exerce considerável impacto na VDI do besilato de anlodipino. A análise das variáveis em seus componentes lineares e quadráticos permitiu a proposição de um modelo matemático que descreve a VDI em função dos parâmetros estudados. Por outro lado, os níveis de pressão de compactação e velocidade de rotação empregados exercem efeito menos relevantes, especialmente quando o ensaio é conduzido em HCl 0,1 M.
Subject(s)
Solid Waste Compaction , Dissolution/classification , Amlodipine Besylate, Olmesartan Medoxomil Drug Combination/pharmacology , Research Design , Antihypertensive Agents/analysisABSTRACT
Objective:To establish an HPLC method compatible with the mass spectrometry for the determination of the content and related substances in amlodipine besylate tablets. Methods:The sample was separated on a CAPCELL PAK C18 column (250 mm × 4. 6 mm, 5 μm) with the mobile phase consisting of methanol and 20 mmol·L-1 ammonium acetate (60∶40) at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 237 nm. The column temperature was 35℃ and the injection volume was 20 μl. Be-sides, an HPLC-QTOF MS method was used to identify the molecular structure of the related substances of amlodipine. Results: The related substances were completely separated from amlodipine. The linear range of amlodipine besylate was 10-100 μg · ml-1 ( r =0. 999 8), and the mean recovery was 99. 2%(RSD=1. 0%,n=9). The main related substances could be detected by HPLC-QTOF MS. Conclusion:The established method is accurate, reliable and reproducible, which can be used in the quality control of amlodip-ine besylate tablets.
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A simple, precise and rapid reverse-phase HPLC method has been developed and subsequently validated for the simultaneous estimation of Amlodipine besylate and Enalapril maleate from their combination drug product. The proposed RP-HPLC method utilizes a Phenomenex C18, 5 μm, 250 mm × 4.6 mm i.d. column, at ambient temperature, optimum mobile phase consisted of Methanol: Acetonitrile : Water (40:50:10, v/v/v), effluent flow rate monitored at 1.0 mL min-1, and detection using PDA detector. The described method was linear over the range of 0.5-6.0 g/ml and 0.5-8.0 g/ml for Enalapril maleate and Amlodipine besylate, respectively. The mean recovery was found to be 100.06 ± 0.49 % and 99.98 ± 0.63 % for Enalapril maleate and Amlodipine besylate, respectively. The intermediate precision data obtained under different experimental setup, the calculated value of coefficient of variation (CV, %) was found to be less than critical value. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.