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IJPRT. 2013; 3(1): 01-04

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

Nakarani Pradip P, Patel Dhaval M.


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.

Key words: Stability indicating HPTLC method, Acebrophylline

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