Development and validation of high performance thin layer chromatographic method for the determination of voglibose in bulk and their formulations

Abstract

To develop a simple, fast, specific, precise and accurate High Performance Thin Layer Chromatographic method (HPTLC) for the determination of Voglibose in bulk and their dosage forms. The chromatographic separation was achieved on precoated silica gel 60F254 aluminum plates using a combination of acetonitrile: methanol: ammonia (15:4:0.1 % V/V/V) as mobile phase and densitometric evaluation of spots was carried out at 284 nm using Camag TLC scanner III with CATS 1.3.4 version software. The experimental parameters like band size of the chamber saturation time, spot application, slit width, solvent front migration, etc. were studied critically and evolved optimized conditions. The drug was well resolved satisfactorily with Rf value 0.66±0.03. The repeatability and accuracy of the optimized method were ascertained by evaluating various validation parameters like linearity (100 to 450 ng/spot), precision (intra-day % RSD 0.21 to 0.74, inter-day % RSD 0.21 to 0.29), accuracy (99.8% to 101.2%, % RSD below 1%), and specificity according to ICH guidelines. The limits of detection and quantification were 40 ng/spot and 100 ng/spot respectively. The developed HPTLC method was faster and cost effective quantitative control for routine analysis of Voglibose in bulk and its formulations.