応用薬学ジャーナル
オープンアクセス

概要

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN PHOSPHATE AND SIMVASTATIN IN BULK AND TABLET DOSAGE FORM

Vinit Chavhan, Minal Ghante & Sanjay Sawant

A simple and new Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed for the simultaneous estimation of Sitagliptin phosphate and Simvastatin in bulk and tablet dosage form. Separation was achieved with aHi-Q Sil C18(250 mm × 4.6 mm, 5 μm Particle size) column at ambient temperature in isocratic mode withmobile phase containing acetonitrile, methanol and 10 mM phosphate buffer (65:25:10 % v/v/v) pH 4 adjusted with orthophosphoric acid, pumped at flow rate of 1.2 ml/min and eluent was monitored at250 nm. The selected chromatographic conditions were found to be effectively separate Sitagliptin phosphate and Simvastatin with retention time of 2.2 and 6.8 min respectively. The proposed method was validated as per ICH guidelines for linearity, precision, accuracy, LOD and LOQ. Both the drugs found to be linear within the conc. range of 100-600 and 20-120 μg/ml for Sitagliptin phosphate and Simvastatin respectively. The results of validation parameters indicates that the proposedmethod was also found to be accurate, precise, robust and sensitive. It can also beused for routine quality-control analysis of these drugs in combination tablets