Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND SITAGLIPTIN IN TABLETS

Prajapati Jhanvi* and Priyanka Yadav

ABSTRACT

Stability indicating RP-HPLC method was developed for Simultaneous estimation of Dapagliflozin and Sitagliptin in tablets under different stability environments of acid, base, thermal, oxidation, and photolytic degradation. Separation was achieved on Zorbax, SB-C18, (250 mm x 4.6 mm) 5.0 μm column by using a mobile phase (Phosphate buffer pH 5.8:ACN) (50:50) with Isocratic flow rate of 1.0 ml/min and detection was at 215 nm. The retention time of Dapagliflozin was found to be 3.06 min and Sitagliptin was found to be 5.82 min. The method was linear in the range of 10 – 30μg/ml, & 100 – 300μg/ml and correlation coefficient was found to be 0.999 for Dapagliflozin and Sitagliptin. The developed method was validated according to the ICH guidelines. The developed method was validated system suitability, specificity, linearity, limit of detection and quantitation, accuracy, precision and robustness. Results of each parameter meet with this acceptance criteria. Hence, the method will be useful for routine quality control analysis.

Keywords: Dapagliflozin, Sitagliptin, RP-HPLC, Validation.