Development and Validation of RP-HPLC Method for Simultaneous Estimation of Amlodipine and Indapamide in Bulk and Tablet Dosage Form

A simple, rapid and precise RP-HPLC method is developed and validated for the simultaneous estimation of amlodipine besylate and indapamide in both bulk drug and combined pharmaceutical-dosage form. The method is based on Ultra Performance Liquid Chromatography (UFLC) on a reversed-phase column, Enable, ODS (C18), 250 mm × 4.6 mm & 5 μm, using a mobile phase of mixed phosphate buffer (pH 4.0) : Acetonitrile (40:60 v/v). The optimum chromatographic conditions to obtain the resolution was flow rate 1.0 mL/min, column temperature at 22 C and detector wavelength at 247 nm. Both the drugs were well resolved on the stationary phase and the retention times was around 3.5 minute for amlodipine besylate and 4.8 minute for indapamide. The method validation data establish precision, linearity, specificity, limit of detection, limit of quantification and robustness parameters. The linear calibration range was found to be 1 to 10 μg/mL for amlodipine besylate and 0.3 to 3 μg/mL for indapamide. The proposed method can be successfully applied to the pharmaceutical dosage forms containing the above-mentioned drug in combination without any interference by the excipients.