Development and validation of a HPTLC method for simultaneous estimation of Drotaverine Hydrochloride and Diclofenac Potassium in combined dosage form
By Snehal S. Ingale, Dipali D. Tajane, Vikram G. Modak, Sacchidanand R. Gite, Vishnu P. Choudhari, Bhanudas S. Kuchekar
A simple, precise, rapid and accurate HPTLC method has been developed for the simultaneous estimation of Drotaverine Hydrochloride (DRO) and Diclofenac Potassium (DFK) in bulk and pharmaceutical dosage form on silica gel precoated aluminum 60F254 plates, (20 cm x10 cm) with 250 μm thickness. The separation was carried out using Toluene: Ethyl acetate: Methanol (2:8:2 v/v/v) as mobile phase. The densitometric scanning was carried out at 298 nm. The Rf values were found to be 0.28 ± 0.05 for DRO and 0.51 ± 0.05 for DFK. The linearity was obtained in the range 160-1280 ng/band and 100-800ng/band with correlation coefficients (r2 = 0.99958) and (r2 = 0.99959) for DRO and DFK, respectively. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The percentage recovery obtained for DRO and DFK were in the range of 99.87-101.20% and 98.39-101.42%, respectively. The proposed method was optimized and validated as per the ICH guidelines.
Keywords: Drotaverine Hydrochloride, Diclofenac Potassium, HPTLC, Method Validation.