Development and Validation of Stability Indicating HPTLC Method for Estimation of Acebrophylline in Their Dosage Form

Abstract

A rapid, accurate and precise stability indicating HPTLC method has been developedandvalidatedfor the estimation of Acebrophylline in pharmaceutical formulation. In this method, standard andsample solutions of Acebrophylline were applied on pre-coated 6 x 10 silica gel 60F254 TLC plate, and developed using Toluene: Methanol:Acetone (8: 2: 2v/v) as mobile phase. Acebrophylline was well resolved at Rf 0.49 ±0.03. A Camag HPTLC system comprising of Camag Linomat-5- applicator, Camagtwin trough chamber, Camag TLC-4 scanner operated with WINCATS software, was used for theanalysis. The drugs on the plate were scanned at 247 nm. The response for the drug was found to be linear in the concentration range 600-2200 ng/band for Acebrophylline with correlation coefficient of 0.9992.The LOD and LOQ were found to be 1.133ng/band and 3.434ng/band respectively by standard equation method.Acebrophyllinewas exposed to acid & base hydrolysis, oxidation and heat. Under all these stress conditions, degraded productswerewell separated. The method was validated according to the ICH guidelines with respect toaccuracy, precision, linearity, specificity, limits of detection and limits of quantitation. As the proposed method could effectivelyseparate the drug from its degradation products, it can be employed as stability indicating method.