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Einstein International Journal Organization(EIJO)

An International Journal House

Einstein International Journal Organization(EIJO)

Connecting People With Genius Thought

Einstein International Journal Organization(EIJO) is an international Genius Thought journals platform .
JOURNALS ||
Modified HPLC Quantification Analytical Technique for Canagliflozin and Metformin Hydrochloride in Bulk and Tablets

Author Names : 1Aditya Trivedi, 2Noopur Dixit, 3D.N.Jhade  volume 1 issue 1
Article Overview

Abstract 

An accurate, precise, specific modified HPLC method was developed for the simultaneous quantification of canagliflozine and metformin in bulk and dosage forms. A C18 column (250 x 4.6mm; 5 µm Phenomenex) with mobile phase containing 0.05% v/v triethylamine (pH6.5): acetonitrile (45:55% v/v) 200C was used and isocratic pump is used for elution and eluents were monitored at 215 nm. The retention times of canagliflozine and metformin  were 3.4 min and 12.7 min respectively and showed a good linearity in the concentration range of 40-200 µg/mL of canagliflozine have found correlation coefficient of 0.999 and 10- 50 µg/mL of  metformin  with a correlation coefficient of 0.998. The average percent recoveries were found to be 98.60% and 98.90% respectively for canagliflozine and metformin.The developed method fallows all the validation parameters like accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method was validated as per ICH guidelines and successfully applied to the simultaneous estimation of canagliflozine and metformin in bulk and dosage form.

Keywords: Canagliflozine, Metformin, Simultaneous Estimation, Phenomenax C18 Column, RP-HPLC, PDA Detection, Validation.

Reference

[1]. Schernthaner, Guntram, et al. "Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea." Diabetes care 36.9 (2013): 2508-2515.

[2]. Nisly, Sarah A., Denise M. Kolanczyk, and Alison M. Walton. "Canagliflozin, a new sodium-glucose co-transporter 2 inhibitor, in the treatment of diabetes." American Journal of Health-System Pharmacy 70 (2013): 311-319

[3]. Wiernsperger, Nicolas F., and Clifford J. Bailey. "The antihyperglycaemic effect of metformin." Drugs 58.1 (1999): 31-39.

[4]. Snyder, Lloyd R., Joseph J. Kirkland, and Joseph L. Glajch. Practical HPLC method development. John Wiley & Sons, 2012.

[5]. Shabir, Ghulam A. "Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization." Journal of chromatography A 987.1 (2003): 57-66.

[6]. Chandran, S., and R. S. P. Singh. "Comparison of various international guidelines for analytical method validation." Die Pharmazie-An International Journal of Pharmaceutical Sciences 62.1 (2007): 4-14.

[7]. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, “Validation of analytical procedure: Methodology. ICH Q2 (R1). Geneva (1996).