ABSTRACT
Abstract Epilepsy is a disorder of the central nervous system, in which the nerve cell activity in the brain is disturbed causing seizures. The objective was to develop an RP-HPLC method for consistent simultaneous quantitation of four antiepileptic drugs Levetiracetam (LVT), Lamotrigine (LTG), Phenobarbital (PBT) and Phenytoin (PTY). An isocratic method was developed on C18 column in JASCO HPLC using 5 mM potassium phosphate buffer (pH 6) and acetonitrile as the mobile phase at a flow rate of 1ml/min and detected at 230 nm using UV detector. The mean retention time for LVT, LTG, PBT and PTY were found as 2.55, 3.55, 4.65 and 5.99 minutes respectively. The method was validated as per ICH guidelines and was found to be acceptable. The %RSD value was <2.0 % thus stating the developed method was precise for the drugs in the given range. The accuracy values were within 85-115% of the recovery range. The specificity of the method was evaluated by an assay of marketed formulation, and it showed a percent content between 90-110% w/w for all the four drugs. The proposed analytical method was simple, accurate and robust and was precisely able to resolve the four major antiepileptic drugs. Hence, the current method can be applied successfully for routine examination of these drugs
Subject(s)
Pharmaceutical Preparations/analysis , Chromatography, Reverse-Phase/methods , Anticonvulsants/analysis , Epilepsy/pathologyABSTRACT
Lidocaine (LDC) and prilocaine (PLC) are estimated in a topical local anesthetic cream using a direct, eco-friendly,stability-indicating gas chromatographic technique with flame ionization detector. The mixture of LDC and PLCwas separated using Zebron DB drug column. The column temperature and flow rate were 230°C and 14 ml/minute,respectively. The retention time was found to be 5.1 minutes for PLC and 5.4 minutes for LDC. Linearity was observedin the concentration range of 20–100 μg/ml and 10–50 μg/ml for LDC and PLC, respectively. The method was validatedand values of linearity, limit of detection, limit of quantification, precision, and accuracy were found to be in goodaccordance with the International Conference on Harmonization guideline. A direct, stability-indicating method wasdeveloped for the determination of LDC and PLC in topical dosage forms in the presence of its degradation products.The proposed method can be useful in the quality control of LDC and PLC in their topical formulation.
ABSTRACT
Lidocaine (LDC) and prilocaine (PLC) are estimated in a topical local anesthetic cream using a direct, eco-friendly,stability-indicating gas chromatographic technique with flame ionization detector. The mixture of LDC and PLCwas separated using Zebron DB drug column. The column temperature and flow rate were 230°C and 14 ml/minute,respectively. The retention time was found to be 5.1 minutes for PLC and 5.4 minutes for LDC. Linearity was observedin the concentration range of 20–100 μg/ml and 10–50 μg/ml for LDC and PLC, respectively. The method was validatedand values of linearity, limit of detection, limit of quantification, precision, and accuracy were found to be in goodaccordance with the International Conference on Harmonization guideline. A direct, stability-indicating method wasdeveloped for the determination of LDC and PLC in topical dosage forms in the presence of its degradation products.The proposed method can be useful in the quality control of LDC and PLC in their topical formulation.
ABSTRACT
ABSTRACT A sensitive and reliable high performance thin layer chromatography method has been developed for the simultaneous estimation of quercetin and gallic acid in Leea indica, Vitaceae. Ethyl acetate extract prepared from hydrolysed aqueous alcoholic extract (70%) was applied on silica gel G 60 F254 plate. The plate was developed using toluene-ethyl acetate-formic acid, 5:4:1 (v/v/v) as a mobile phase and detection and quantification were performed by densitometric scanning at 254 nm. The system was found to give well resolved bands for quercetin (Rf 0.63) and gallic acid (Rf 0.45) from other constituents present in the extract of L. indica. The correlation coefficient was found to be 0.991 and 0.999 with relative standard deviation, 0.97–1.23% and 0.1–1.13% for quercetin and gallic acid respectively in the developed method. The accuracy of the method was confirmed by conducting recovery studies at different levels using the standard addition method. The average recovery of quercetin and gallic acid was found close to 99% suggesting the accurateness of the method. The proposed validated high performance thin layer chromatographic method offers a new, sensitive, specific and precise gauge for quantification of quercetin and gallic acid in L. indica.
ABSTRACT
A new high performance liquid chromatography (HPLC) with ultraviolet detection method is developed for the simultaneous quantification of acetaminophen and tramadol in bulk and in its combined pharmaceutical dosage form. The chromatographic separation was performed on Waters symmetry C8 column (250 mm × 4.6 mm I.D., 5 μm particle size) using isocratic elution. The optimized mobile phase consists of phosphate buffer (pH 6.8) and methanol (80:20, v/v). The eluted analytes are monitored at 215 nm wavelength using a UV detector. The developed method separates acetaminophen and tramadol within a run time of 6 min. The developed method was validated as per International Conference of Harmonization guidelines with respect to linearity, sensitivity (limit of detection and limit of quantification), selectivity, accuracy, precision and robustness. The developed and validated method was successfully applied to the determination of acetaminophen and tramadol in combined pharmaceutical dosage forms without any interference from the excipients with good recovery, precision and accuracy.
ABSTRACT
A simple, accurate, sensitive, economical and reliable first order derivative spectrophotometric method was developed and validated for the estimation of cefixime and moxifloxacin in pharmaceutical dosage form. The optimum conditions for the analysis of the drugs were established. First order derivative method was developed for quantification of cefixime and moxifloxacin. Spectrum was obtained by dissolving cefixime and moxifloxacin in methanol and water (60:40 v/v); wavelength selected was 260 nm for cefixime and 316 nm for moxifloxacin. The Beer’s law was obeyed in the concentration range of 2-12 μg/ml. Results of tablet analysis showed percent relative standard deviation (% RSD) in the range of 0.1576 to 0.2183 for cefixime and moxifloxacin which indicate repeatability of the method respectively. Recoveries do not differ significantly from 100% which show there was no interference from the common excipient used in tablet formulation indicating accuracy and reliability of the method. The method was validated as per ICH guideline and found to be accurate, precise and rugged. It was also validated in terms of linearity, accuracy, precision, and specificity, limit of detection and limit of quantitation.
ABSTRACT
A simple, specific, and accurate reverse phase liquid chromatographic method was developed for the estimation of Tizanidine (TZN) and Baclofen (BCF) in combination. A Phenomenex -C18 (150×4.60 mm Dimensions, 5μm Particle size) column with mobile phase containing methanol: water (53:47) was used at isocratic mode and eluents were monitored at 228 nm. The retention times of TZN and BCF were 2.03 and 4.1min respectively and both the drugs showed good linearity in the concentration range of 10-50 μg/mL with a correlation coefficient (R) of 0.9992 and 0.9993 respectively. The proposed method was validated as per ICH guidelines and method showed good precision with percent relative standard deviation less than 2%. The percentage assay values of TZN and BCF were found to be 99.72 and 98.56 respectively and recovery values are within the limits of 98-102% indicating the proposed method was accurate and precise for the simultaneous estimation of TZN and BCF in bulk and pharmaceutical dosage forms.
ABSTRACT
The study describes development and subsequent validation of an RP-HPLC-PDA method for the simultaneous estimation of Tamsulosin (TAM) and Finasteride (FIN) in bulk and tablet dosage form. The chromatographic conditions comprised of a reversed-phase C18 column (150 x 4.6 mm, 5 μ) with a mobile phase consisting of a mixture of methanol and formic acid (0.02% v/v in water) at a flow rate of 1 mL/min and ran in gradient mode. Detection was carried out at 230 nm. The retention times were 2.7 min and 10.08 min respectively for TAM and FIN. A good linear relationship in the concentration range 0.4-20μg/mL with a correlation coefficient of 0.9981 for TAM and in the range of 5-50μg/mL a correlation coefficient of 0.9987 was observed. Limit of detection (LOD) was found to be 0.16μg/mL for TAM and 0.6μg/mL for FIN. The method was validated for accuracy, precision, robustness and assay. The percent recovery values were in the ranges of 99.15-100.8 for TAM and 99.21-101.83 for FIN. The results of all the validation parameters were well within their acceptance values.
ABSTRACT
A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the simultaneous estimation of ibuprofen and famotidine in tablet dosage forms using C18 column (Phenomenex, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of Methanol: Water: Phosphate buffer in the ratio of 70:20:10 (v/v/v). The flow rate was 1.0 ml/min and detection wavelength was carried out at 284 nm. The retention times of ibuprofen and famotidine were 3.6 min and 7.8 min, respectively. The method was linear over the concentration range for ibuprofen 2-10 μg/ml and for and famotidine 2-10 μg/ml. The recoveries of ibuprofen and famotidine were found to be in the range of 99.037-100.766% and 99.703-100.433% respectively. The validation of method was carried out utilizing ICHguidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.