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 were performed on 100mm x 100mm layer thickness 0.2 mm, pre-coated silica gel 60F254 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 600-1600 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 220nm in a reflectance mode. The proposed 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.