Abstract

METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE AND SAXAGLIPTIN BY RP-HPLC

Aruna Kumari .Bondu1, Raju.Chipirishetti, Bhavani .Pillutla, Pavani .Bodapati , Prasadarao.Ch, Sivannaraya.Talari

Abstract

A new simple, rapid,economical reverse phase high performance liquid chromatographic method was developed for the determination of Metformin Hcl [MFH] and Saxagliptin [SGP] in bulk and dosage form. The separation was eluted on a Thermo Hypersilbds c18(150mm x5 mm i.d. ,6μm) using a mobile phase mixture of potassium dihydrogen Phosphate buffer (0.05M) pH 6.8 and methanol in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. Water is used asa diluent The detection was made at 294nm. The retention times were 1.4min for Metformin. Hydrochloride and 2.4min for Saxagliptin . Calibration curve was linear over the concentration range of 125-375μg/ml for Metformin.hydrochloride and 1.25 to 3.75 μg/ml for Saxagliptin mean recoveries obtained for metformin.hcl and saxagliptin were 99-100% and ,99-101% respectively.The propose method was validated as per the ICH guidelines parameters like Linearity, precision, accuracy, robustness limit of detection and limit of quantitation. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.

Keywords: Saxagliptin, Metformin.Hydrochloride Tablets, C18 column, RP-HPLC.