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Stability indicating HPTLC method for the determination of pregabalin in bulk and pharmaceutical dosage forms

B.S.Jaswanth Kumar, R.V.Kumar, V.R.Sinha

The present study focuses on the development, validation and force degradation studies of Pregabalin using high performance thin layer chromatography (HPTLC). The method was developed by optimizing the mobile phase with butanol:methanol: water : glacial acetic acid with a ratio of 8: 1: 1: 0.1. A good correlation coefficient was observed in the concentration range of 200 ng/spot- 1000 ng/spot. The developed method was validated for intraday and inter-day precision and low percentage RSD values of 1.65 and 1.73 % respectively, were observed indicating the suitability of the developed method. The proposed method was also used for assay of capsules. Recovery studies were performed and it was found that the method is accurate, sensitive and selective for the analysis of the drug. Force degradation studies were carried out using ICH tripartite guidelines and found that the drug is stable in neutral, acidic, thermal and photolytic conditions. However, it showed a degradation of approximately 54.99%on exposure to alkaline stress conditions and 55.13 % on exposure to the oxidative stress conditions.