Абстрактный

Validated HPTLC Method for Simultaneous Estimation of Sitagliptin and Metformin Hydrochloride in Bulk Drug and Formulation.

Snehal V Warghade, Neha N Devlekar, Ravindra Y Patil, and Vijaya U Barge

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of two anti-diabetic drugs, sitagliptin and metformin hydrochloride in bulk and tablet dosage form. Study was performed on TLC plates precoated with silica gel 60F254 using methanol: ammonia: glacial acetic acid (9.4:0.4:0.2 v/v/v)as the mobile phase. A TLC scanner set at 214 nm was used for direct evaluation of the chromatograms in the absorbance mode. Method was validated according to ICH guidelines. The correlation coefficients of calibration curves were found to be 0.999 and 0.998 in the concentration range of 100–1100 and 1000–11000 ng band-1for sitagliptin and metformin, respectively. The method had an accuracy of 99.70% for sitagliptin and 100.02% for metformin hydrochloride. Intra and inter day precision measured as coefficient of variation were less than 2% for both analytes. The limit of detection and quantitation were 7.08 ng band-1 and 21.82 ng band-1, respectively for sitagliptin and 19.31 ng band-1 and 58.51 ng band-1, respectively for metformin hydrochloride. The method had the potential to determine these drugs simultaneously from dosage form without any interference of the tablets excipients