Study of “Simultaneous Analytical Validation of Stability Indicating RP- HPLC for Metformin-Canagliflozin”

Abstract

A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Metformin Hydrochloride and Canagliflozin in bulk and dosage forms. The method involves separation Agilent C18 (250x4.6mm) 5 particle size. The optimized mobile phase consists of Potassium Di hydrogen Phosphate Buffer (pH 3.2 0.1) and Acetonitrile (60:40 v/v) with a flow rate of 1ml/min and UV detection at 240 nm. Retention time was 2.209 min (Metformin Hydrochloride), 4.799 min (Canagliflozin). Linearity range was 50-150 ug/ml (Metformin Hydrochloride), 5.0-15ug/ml (Canagliflozin). Accuracy was in the range of 100.23-100.1% for both drugs Metformin Hydrochloride and Canagliflozin. Precision was 0.146% and 0.058% for Metformin Hydrochloride and Canagliflozin. LOD and LOQ are 0.15ug/ml and 0.46 ug/ml for Metformin Hydrochloride, 0.19ug/ml and 0.58ug/ml for Canagliflozin. The method developed is more sensitive, accurate and precise than the methods reported earlier. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 99.92-100.1% of labeled content. Forced degradation studies indicated the suitability of the method for stability studies.

 Keywords:Metformin Hydrochloride , Canagliflozin , RP-HPLC Method , Simultaneous Analytical Validation , ICH Guidelines