Gurmeet Singh, Amrita Parle and Komal Sharma
Delhi Institute of Pharmaceutical Sciences and Research, India
Posters-Accepted Abstracts: J Pharma Care Health Sys
A new, simple, precise, accurate and selective high performance thin-layer chromatographic method has been developed and validated for the estimation of alogliptin benzoate in bulk and tablet dosage form. Chromatographic separation was carried out on Merck HPTLC aluminium sheets of silica gel 60F254 using acetonitrile: 1% ammonium acetate in methanol (4.5:5.5 v/v) as mobile phase followed by densitometry analysis at 277 nm. The reliability of the method was assessed by evaluation of linearity (500-5000 ng/spot for alogliptin benzoate. The accuracy of method was assessed by recovery studies and was found to be within range of 98- 102%. The developed method was validated with respect to linearity, accuracy (recovery), and precision. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory. Due to non-availability of product, 400 mg tablets were punched containing 34 mg alogliptin benzoate. The proposed method was successfully applied for the determination of alogliptin benzoate in the tablet dosage form.
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