Stability Indicating RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Pharmaceutical Dosage Form

Prathap.B^1*, Haribaskar.V², Kumar.B³, Ramesh Dhani⁴, Bhavya.CH⁵, Kavitha.M⁶, Harika.S⁷
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Nellore – 524346, Andhra Pradesh, India.

 A B S T R A C T
A simple, sensitive, accurate, precise and stability indicating RP-HPLC method has been developed for the simultaneous estimation of saxagliptin and dapagliflozin in combined pharmaceutical dosage form. The analysis was carried out at 225nm and the chromatographic separation was achieved with spursil C18 [250 X 4.6 X 5µ] column under 25°C temperature and using mobile phase 0.1%OPA (buffer): methanol: acetonitrile in a ration of 30:60:10v/v/v buffer pH adjusted to 3.8. The retention timef of saxagliptin and dapagliflozin were found to be 2.340 min and 5.081min respectively. The proposed method was validated according to ICH guidelines. The linearity study of saxagliptin and dapagliflozin was found in concentration range of 10 – 50 µg/ml and 20 – 100µg/ml and coefficient (r2) was found to be 0.9998 and 0.9991. The percentage recovery was obtained as 99.86%v/v and 100.64%v/v for saxagliptin and dapagliflozin. The percentage RSD was found to be less than 2.0%. The studies were carried out by conducting deliberate degradation of the sample with exposure to stress conditions like acidic, alkaline, thermal, oxidizing agent and light. This method was validated and met the regulatory requirements for specificity, linearity, LOD, LOQ, precision, accuracy, robustness and stability for the determination of saxagliptin and dapagliflozin in pharmaceutical dosage form by RP-HPLC.
Keywords: Saxagliptin, Dapagliflozin, RP-HPLC method