Abstract

BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR METFORMIN AND CANAGLIFLOZIN BY RP-HPLC

Syeda Kulsum*, Prof. Dr. G. Vidya Sagar, Dr. R. Senthilkumar and Prof. Dr. Syed Mohammed Kazim

ABSTRACT

Bioanalytical method development is the process of creating a procedure to enable a compound of interest to be identified and quantified in a biological matrix. A simple, selective, rapid, precise and economical Reverse-Phase HPLC method has been developed and validated for quantitative determination of Metformin and Canagliflozin. Metformin Hydrochloride is an orally administered biguanide derivative used to lower blood glucose concentration in patients with non insulin dependent diabetes mellitus. Canagliflozin is an anti diabetic drug used to improve glycemic control in patients with type 2 diabetes. Pioglitazone is used as an internal standard. The method was carried out with Waters HPLC with auto sampler and PDA detector. Spursil (Dikma) ODS C 18 column (4.6 x 250mm, 5m) is used at a flow rate of 1.0mL/min. Detection was carried out at 254 nm. The mobile phase used is Phosphate buffer (pH 3.0) with Acetonitrile in proportion 85: 15 v/v respectively. The retention times of Metformin and Cangliflozin were 4.738min and 8.352min respectively. The method was developed and tested for linearity range of 250 to 1250 ng/mL for Metformin HCl and 25 to 125 ng/mL for Canagliflozin. These bioanalytical validations play a significant role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies. In which different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed.

Keywords: Metformin Hydrochloride, Canagliflozin, RP-HPLC Method, Validation.