APPLICATION OF HPTLC-DENSITOMETRIC ANALYSIS FOR SIMULTANEOUS DETERMINATION OF CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE AND PANTOPRAZOLE SODIUM IN THEIR COMBINED CAPSULE DOSAGE FORM

Abstract

A simple, precise, accurate and reliable HPTLC method has been developed and validated for analysis of Clidinium Bromide (CLBr ), Pantoprazole Sodium (PNT) and Chlordiazepoxide ( CDZ) in their combined dosage form. Identification and analysis we re performed on 100mm x 100mm layer thickness 0.2 mm, pre - coated silica gel 60F 254 aluminum sheet, prewashed with methanol and dried in an oven at 50°C for 5 min. Chloroform: Acetone: 0.5M Ammonium acetate in Methanol: Formic acid (1.0:5.0:3.0:1.0) (v/v/v/ v) was used as mobile phase. Calibration plots were established showing the dependence of response (peak area) on the amount chromatographed. The validated calibration ranges were 600 - 1 6 00 ng/spot , 4800 - 12800ng/spot and 1200 - 3200 ng/spot for CLBr, PNT and CDZ with correlation coefficient (R 2 ) 0.998, 0.994 and 0.998 respectively . Average % recovery was between 99.63 – 99.89%, 99.87 – 100.05% and 99.77 - 99.93 % for CLBr, PNT and CDZ respectively. The spots were scanned at 220 nm in a reflectance mode. The propo sed method has been validated as per ICH guidelines and successfully applied to the estimation of CLBr , PNT and CDZ in their combined Capsule dosage form.