Development and application of RP-HPLC method for dissolution study of oral formulations containing amlodipine besylate

Pawar, Harshal Ashok; Yadav, Akanksha

Abstract

A rapid, robust and specific reversed-phase HPLC method has been developed and validated for quantitative estimation of amlodipine besylate in the dissolution study of oral films by direct injections of aqueous solutions. The study involve isocratic elution of amlodipine besylate in Zorbax® Eclipse XDB-C18 analytical column using buffer (0.7% aqueous triethylamine adjusted to pH 3.0 with orthophosphoric acid) and methanol in the ratio of 40:60 (v/v). The aqueous solutions are analysed at a flow rate of 1.0 mL/min at 239 nm. The method presents linearity (r2= 0.999) in the concentration range 20-150 µg/mL. The result indicates good recoveries ranging from 98.06% to 99.22%. The method show good precision with % RSD value less than 2. All the validation parameters are within the acceptance range. The developed method can be successfully employed for in-vitro dissolution and routine analysis of formulations containing Amlodipine besylate.

Keyword(s)

Amlodipine besylate; Filter evaluation; HPLC; ICH guideline; Method validation; Pharmaceutical film

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