Development and Validation of Stability-Indicating RP-HPLC Method for Determination of Indapamide and Amlodipine Besylate

Abstract

A new simple, accurate, precise and selective stability- indicating high performance liquid chromatographic (HPLC) method was developed and validated for simultaneous estimation of Amlodipine Besylate and Indapamide in tablet dosage form. An isocratic, reverse phase HPLC method was developed and validated using NUCLEOSIL C18 (250 x 4.6 mm, 5 μm) column and 0.01 M potassium dihydrogen phosphate buffer pH 3 and methanol (30:70 v/v) as mobile phase and detection is carried out at a wavelength of 241 nm. The retention time for IND and AMLO were 3.84 ± 0.02 and 5.96 ± 0.09 m. respectively. The method was validated with respect to linearity, precision, accuracy and robustness. The drugs were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation.