STABILITY INDICATING RP – HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE AND CHLORTHALIDONE IN BULK AND TABLET DOSAGE FORMAbstract
The RP-HPLC stability-indicating assay method has been developed and validated for the estimation of the amlodipine and chlorthalidone in bulk and combined dosage form. The method was optimized by using the mobile phase as a mixture of 0.1% formic acid: methanol: acetonitrile in the ratio of (50:5:45 v/v) at pH 3 was adjusted with orthophosphoric acid. The method was carried out on the Octadecylsilane C18 column (5 µm, 25 cm × 4.6 mm) using a flow rate of 1.0 ml per min. The method was scanned at λmax 266 nm for both the drugs using a PDA detector. The retention time was found to be at 6.32 min and 5.32 min for AML and CHL respectively. The calibration curve determined at respective retention time is found to be 2.5-7.5 μg/ml and 06-18 μg/ml with a regression coefficient of 0.9990 and 0.9940 for AML and CHL respectively. The developed and validated method is reliable, simple, precise and accurate and easy to apply in the laboratories.
P. H. Sakpal * and A. R. Chabukswar
Department of Pharmaceutical Chemistry, Marathwada Mitra Mandal’s College of Pharmacy, Thergaon (Kalewadi), Pune, Maharashtra, India.
18 June 2019
18 October 2019
08 February 2020
01 May 2020