Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF INDAPAMIDE AND AMLODIPINE BESYLATE

Gandhi V. Santosh*, Madhuri M. Karad, Atul A. Baravkar and Padmanabh B. Deshpande

ABSTRACT

A new simple, accurate, precise and sensitive stability- indicating high performance thin layer chromatographic (HPTLC) method was developed and validated for simultaneous estimation of Indapamide and Amlodipine besylate in bulk and in tablet dosage form. The chromatographic development was carried out on precoated silica gel 60 F254 aluminium plates using mixture of Chloroform: Glacial acetic acid: Methanol (8.5: 1: 0.5 v/v) as mobile phase and densitometric evaluation of bands at 241 nm using Camag TLC Scanner-3 with win CAT 1.4.3 version software. The Rf value of Indapamide and Amlodipine besylate were found to be 0.69 ± 0.02 and 0.29 ± 0.02, respectively. The method was validated with respect to linearity, accuracy, precision and robustness. The calibration curve was found to be linear over a range of 100 - 1000 ng/ band for Indapamide and 500 – 3000 ng/ band for Amlodipine Besylate. The drugs were subjected to stress condition of hydrolysis (acid, base, neutral), oxidation, photolysis and thermal degradation.

Keywords: Indapamide, Amlodipine besylate, HPTLC, Stability.