ABSTRACT
A method for simultaneous estimation of Atorvastatin Calcium (AVS) and Amlodipine Besilate (AML) in combined tablet dosage form has been developed. The method employs the application of multicomponent mode of analysis. This method utilize Phosphate buffer (pH6.8). AVS show maximum absorbance at a wavelength of 240 nm and AML at 369 nm. The method is fast,economical and very cheap as compared to other simultaneous spectrophotometric method using multi-component mode of analysis for estimation of Atorvastatin Calcium and Amlodipine Besilate due to using phosphate buffer instead of costly solvent.Where the linearity ranges for AVS and AML were 5-25μg/ml and 10-50 μg/ml respectively. The procedure was successfully applied for the simultaneous determination of both drugs in laboratory prepared mixture and in market available tablet dosage form. The accuracy of the method was assessed by recovery studies and was found to be 99.41±0.83 and 98.65±0.54 for AVS and AML respectively. Results of the analysis were validated statistically so that it can be used for routine analysis of AVS and AML in combined tablet dosage form.
ABSTRACT
The purpose of the study was to develop a bilayer tablet of Amlodipine besilate (IR) and Metoprolol succinate (SR) having different release pattern, which is indicated for the management of hypertension. The study was planned in three stages. In the first stage six batches (A1, A2, A3, A4, A5 and A6) of immediate release tables of Amlodipine besilate was prepared by direct compression method using sodium starch glycolate and pre-gelatinised starch as super disintegrant. In the second stage, six batches(M1, M2, M3, M4, M5, M6) of Metoprolol succinate sustained release part was prepared using HPMC polymers as rate retardant. Preformulation studies were performed prior to compression. In the third stage compressed bilayer tablets were evaluated for weight variation, dimension, hardness, friability, drug content, and disintegration time and invitro drug release using RP-HPLC. DSC studies revealed no disturbances in the principle peaks of pure drugs Metoprolol succinate and Amlodipine besilate and it confirms the integrity and compatibility of pure drugs with their excipients. The stability studies were performed for optimised batch for three months and it showed acceptable results.
ABSTRACT
BackgroundAmlodipine is one of the products included in Mongolian Essential Medicine list. Local drug manufacturers don’t produce this product and our country imports this product from several countries. Drug research institute has developed the technology to produce Amlodipine 10 mg tablet on the scientific basis and quality determination and stability study have to be performed.GoalThe main aim of this study was to perform quality determination of Amlodipine 10 mg tablet. In the framework of this study quality criteria were determined and HPLC method to determine amlodipine content was developed.Materials and MethodsThe appearance and average weight of tablet determined visual and weight test method instead of Mongolian national Pharmacopeia. Friability, disintegration time, dissolution characteristics determined SY-6D tablet tester equipment. Assay method was instead of British and Russian pharmacopeia used by Shimadzu HPLC equipment[3, 4]. Amlodidine besilate standard substance was made by Sigma-Aldrich company. The microbial limit test determined instead of Mongolian national Pharmacopeia.ResultsOn the result of this study the following results were received: average weight 0.177 g, weight range +6.5, - 2.1; tablet friability 99.57%, disintegration time 7 seconds, dissolution 97%, meet the requirement uniformity of dosage unit. HPLC method to determine amlodipine content was developed and suitable condition for HPLC was: column - octadecylsilane 5μm, 4.6 x 150 mm, mobile phase buffer-acetonitrile-methanol (50:15:35), detection - 237 mn. Bacteria, yeasts, mould and Escherichia coli were absence in Amlodipine 10 mg tablet.ConclusionsDetermined quality requirement of Amlodipine 10 mg tablet. The assay method developed suitable condition of HPLC instead of British pharmacopeia. Bacteria, moulds, yeast and Escherichia coli were absence in Amlodipine 10 mg tablet.