IN VITRO ASSESSMENT OF PHYSICOCHEMICAL PARAMETERS OF FIVE GENERICS AMLODIPINE BESYLATE TABLETS MARKETED IN YEMEN
Keywords:Amlodipine; Quality control; United stat of pharmacopeia, Hypertension.
Objective: The present paper aims to evaluate the quality of five different brands (local and imported) of oral film-coated tablets of generic Amlodipine besylate 5 mg marketed in Sana`a-Yemen, through physiochemical parameters.
Methods: Different physicochemical parameters including the uniformity of tablet weight, hardness, thickness, disintegration time, and an assay of active ingredients were conducted to validate the quality of generics Amlodipine Besylate 5 mg according to USP specification.
Results: From the obtained results, it was observed that all the brands of Amlodipine Besylate 5 mg have passed the tests and met the specifications of USP. Results of weight variation, hardness, thickness, and disintegration time were ranged from -3.8 % to + 5.13 % to -1.25 % to +3.25 %, 5.06 ± 0.31 to 13.21 ± 1.5, 2.682 ± 0.04 to 3.676 ± 0.01 and 25 s to 2 min:30 s, respectively. The dissolution test and the assay results of all the brands are also ranged within the acceptable label claim 93.7 ± 2.24 to 98.4 ± 0.85 and 93.22 ± 0.38 to 100.15 ± 0.33, respectively. However, there is no relation was found between the disintegration time and the dissolution test.
Conclusion: According to the finding, all the selected Amlodipine Besylate 5 mg brands are met pharmacopeia standards and USP specifications. Therefore, the local and imported Amlodipine Besylate 5 mg can be used safely to get the desired therapeutic efficiency.
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