Development and Validation of Novel Stability- Indicating LC Method for the Determination of Saxagliptin and Metformin

Abstract:

Aim: Development of a novel precise, selective and sensitive stability indicating RPHPLC method has been developed and validated for the determination of Saxagliptin hydrochloride (SAX) and Metformin HCl (MET) in bulk drug and pharmaceutical dosage form. Materials and Methods: The separation was carried out on a Phenomenex Luna, SCX, 250 x 4.6mm, 10 μm using a mobile phase of ammonium dihydrogen phosphate buffer pH 2.50: methanol [70:30 % v/v]. Quantitation was achieved using UV detection at 210 nm. Results: The retention times were about 6.2 min for SAX and about 10.4min for MET. Calibration curves were linear over the concentration range from 5-100μg/mL for SAX and 40-800μg/mL for MET. Peak purity of SAX and MET established in presence of all major degradation product in stressed samples. Conclusion: The proposed method of analysis has been validated as per ICH guidelines and proved to be specific, precise, linear, rugged and robust. The effectiveness of the method was demonstrated with marketed pharmaceutical preparation of SAX and MET.

Key words: Saxagliptin, Metformin, Stability indicating, Forced degradation, Pharmaceutical preparation.