DEVELOPMENT AND VALIDATION OF ION PAIR-LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF INDAPAMIDE AND AMLODIPINE BESYLATE IN BULK AND MULTICOMPONENT FORMULATION

Abstract

The present paper report the simple, rapid, accurate and precise ion pair high performance liquid chromatographic method for the simultaneous est imation of Indapamide and Amlodipi ne Besylate in bulk and m ulticomponant formulation. The reverse - phase liquid chromatographic analysis has been performed on a Hypersil C 18 column (250 mm × 4.6mm i.d., 5 μm particle size) column with mobile phase Methanol: Acetonitrile: 0.1 M Heptane sulphonic acid sodium salt (1.5 ml triethylamine was added and pH adjusted to 3.5 with Ortho phosphoric acid ) in the ratio 20:40:40 v/v /v and column temperature at 30°C. The flow rate of the mobile phase was adjusted to 1.0 ml/ min and the injection volume was 10 μl. Detection was performed at 237 nm. The retention ti me for Indapamide and Amlodipine besylate were 4. 1 3 min and 7.64 min respectively. The method was validated and shown to be linear for indapamide and Amlodipine Besy late in 25 - 150 µg/ml (r 2 =0.999) and 100 - 6 00 µg/ml (r 2 =0.999) respectively. The relative standard deviation of Indapamide and Amlodipine besylate for intra - day was 0.2930 and 0.1218 respectively , inter - day was found to be , 0.5905 and 0.2507 respectively. K EYWORD S : Indapamide, Amlodipine Besylate, heptanes sulphonic acid sodium salt, RP - H PLC, ion pair liquid chromatography .