STABILITY INDICATING RP-HPLC METHODS FOR SIMULTANEOUS DETERMINATION OF AMLODIPINE AND PERINDOPRIL IN PHARMACEUTICAL FORMULATION IN THE PRESENCE OF THEIR DEGRADATION PRODUCTS
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Author:
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GHANSHYAM SANGHANI, S S PANDYA, ASHOK AKABARI, USMANGANI CHHALOTIYA
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Abstract:
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The specific, sensitive, and precise stability-indicating RP-HPLC method has been developed, optimized and validated for determination of amlodipine besylate (AML) and perindopril arginin (PER) in their mixtures and in the presence of their degradation products. The method was based on high-performance liquid chromatography, by which the proposed components were separated on a reversed-phase C18 analytical column using mobile phase composition of acetonitrile–0.025M potassium dihydrogen phosphate buffer (30 + 70, v/v) and pH 3.0 adjusted with orthophosphoric acid with ultraviolet detection at 271 nm. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. System suitability parameters of the developed methods were also tested. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the quantification of PER and AML in their commercial tablets.
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Keyword:
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Amlodipine besylate (AML), Perindopril arginin (PER), RP-HPLC
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EOI:
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DOI:
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