DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND INDAPAMIDE IN BULK AND TABLET DOSAGE FORM

Objective: An isocratic reversed-phase liquid chromatograpic assay method was developed for the quantitative determination of amlodipine besylate (AML) and indapamide (IND) in bulk and tablet dosage form. Material and method:A Inertsil C8 (150mm x 4.6mm) column with a mobile phase containing KH2PO4 buffer: Acetonitrile (70:30) total pH-adjusted to 3 using o-phosphoric acid was used. The flow rate was 1.0 mL min−1: 1.5 ml/min and effluents were monitored at 242 nm. Results and conclusion: The retention times of both amlodipine besylate and indapamide were 14 minutes. The proposed method was validated with respect to system suitability, Specificity and selectivity, Stability of analytical solutions linearity, accuracy, precision, and robustness. The method was successfully applied to the estimation of amlodipine besylate and indapamide in bulk and tablet dosage form. Keywords: RP-HPLC, Amlodipine, Indapamide, Tablet, Validation