Abstract
STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SAXAGLIPTIN AND DAPAGLIFLOZIN

Aruna Gundala*, Divya Sree Kammuri and Bharathi K.

ABSTRACT

Saxagliptin and Dapagliflozin are anti diabetic drugs that are used together with proper diet and exercise control high blood sugar levels in people with type 2 diabetes. The present study was to develop a stability indicating RP-HPLC method for simultaneous estimation of Saxagliptin and Dapagliflozin in bulk and tablet dosage forms. The chromatographic separation of these two drugs was achieved on Discovery C18 column (250 × 4.6 mm, 5 μ) as the stationary phase with a mobile phase of water (pH 2.2 adjusted with OPA) : Acetonitrile (55:45 v/v) at a flow rate of 1 ml/min and PDA detection at 210 nm. The retention times of Saxagliptin and Dapagliflozin were found to be 3.601 and 2.785 respectively. The proposed method was validated for system suitability, linearity, accuracy, precision, specificity, LOD, LOQ and robustness. The calibration curves were linear in the concentration range of 25-150% of the working concentration (r2 = 0.999) for both the drugs in binary mixture. The LOD was found to be 0.13 μg/ml and 0.09 μg/ml and LOQ was found to be 0.39 μg/ml and 0.27 μg/ml for Saxagliptin and Dapagliflozin respectively. Accuracy was found to be 99.91 % for Saxagliptin and 100.08% for Dapagliflozin. The percentage recoveries for both drugs were in the range of 99-101%. The method was applied for determination of Saxagliptin and Dapagliflozin in the presence of their degradation products under the variety of stress conditions. The pharmaceutical ingredient was subjected to acid, alkali, water, heat, UV light and oxidative stress conditions and stress samples were analysed by the proposed method. Hence the proposed stability indicating RP-HPLC method can be used in routine analysis of tablets containing Saxagliptin and Dapagliflozin.

Keywords: Saxagliptin, Dapagliflozin, HPLC, stability, method development and validation.


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