Assessment and Comparison of Pharmaceutical Equivalence of Amlodipine Besylate Tablets Available in Syria under Biowaiver Conditions
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There are several generics of Amlodipine besylate tablets locally manufactured by some Syrian pharmaceutical companies. this study tries to evaluate the pharmaceutical and chemical equivalence of amlodipine besylate tablets from 5 Syrian pharmaceuticals and comparison the results with an innovator (Norvasc®). The pharmaceutical equivalence and the quality for each generic were assessed through the evaluation of standard tests such as uniformity of weight, friability, hardness, disintegration, content uniformity, uniformity of dosage units and dissolution rate. The assay was conducted by using HPLC (the analytical column was C 18, 150 x 4.6 mm I.D, 4μm particle size, the mobile phase was a mixture of 30% acetonitrile and 70% 100 mM ammonium acetate pH 5 with flow rate of 1ml/min and UV detection at 237 nm for amlodipine). All the generics complied with the standard specifications for uniformity of weight (<±7.5%), friability (<1%), content uniformity (85–115%), uniformity of dosage units (<15), hardness and disintegration tests. The chromatographic system found to be suitable for quantitative determination of amlodipine (the resolution was 13.587, theoretical plates were 7080, tailing factor was 1.921, RSD% was 1.087). The result of assay indicated that only (B, C, E) showed values out of the range specified in the USP (90–110%) but all products released more than 75% of the labeled quantity during 30 minutes. Only product D had similarity factor (f2) >50. This confirms the need for continuous monitoring of the safety, quality and efficacy of the marketed generic drugs with a view to bioequivalence and agreement with pharmacopoeia standards.
Amlodipine besylate, quality control, content uniformity, dissolution test, pharmaceutical equivalence.