Method Development and Validation of Canagliflozin by using RP-HPLC in Pure and Tablet Dosage Form

Author:

Singh Swapna1,Kumar Bichala Prem1,Agrawal Abhishek1

Affiliation:

1. School of Pharmaceutical Sciences, Pratap University, Sunderpura – 303104, Jaipur, Rajasthan, India.

Abstract

A new method was established for simultaneous estimation of Canagliflozin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Canagliflozin by using INERTSIL column, C18 (150x4.6)5µm column, flow rate was 1ml/min, mobile phase ratio was Water: Acetonitrile (70:30), detection wavelength was 264nm. The instrument used was Hitachi HPLC Auto Sampler, Separation module 1575. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Canagliflozin was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, %mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, %RSD for intermediate precision was 0.5 and 0.1 respectively.

Publisher

A and V Publications

Reference5 articles.

1. International Conference on Harmonization, "Q2A: Text on Validation of Analytical Procedures," Federal Register. 1995, 60, 11260–11262.

2. Ghulam, A. S. PLC Method Development and Validation for Pharmaceutical Analysis. Pharmaceutical Technology Europe. 2004, 7, 55 -63.

3. Radhika, R.; Alfred, D. G. Guidance for Industry- Analytical Procedures and Methods Validation. Federal Register, 2000, 2396, 1-32.

4. https://www.drugbank.ca/drugs/DB08907

5. Sandouk P, Bouvierd'Yvoire M, Chretien P, Tillement JP, Scherrmann JM (January 1994). "Single-dose Apixaban in healthy volunteers". Biopharmaceutics and Drug Disposition 15 (1): 87–92.doi:10.1002/bdd.2510150108. PMID 8161719.

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