The result of quality parameters determination of amlodipine 10 mg tablet / Монголын Анагаах Ухаан

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 (501535), 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.