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Vol. 32 No. 12 (2020): Vol 32 Issue 12, 2020

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Development and Validation of Modern UHPLC-DAD Analytical Method for Simultaneous Determination of Repaglinide and Metformin in Pharmaceutical Dosage Forms

https://doi.org/10.14233/ajchem.2020.22915
Viralkumar Patel
Department of Chemistry, HVHP Institute of Post Graduate Studies and Research, Kadi Sarva Vishwavidyalaya, Gandhinagar-382024, India
Chintan Pandya
Department of Chemistry, HVHP Institute of Post Graduate Studies and Research, Kadi Sarva Vishwavidyalaya, Gandhinagar-382024, India
Aditee Pandya
Department of Microbiology, School of Sciences, P.P. Savani University, Dhamdod-394125, India
Zalak Patel
Department of Chemistry, HVHP Institute of Post Graduate Studies and Research, Kadi Sarva Vishwavidyalaya, Gandhinagar-382024, India
Dharmesh Patel
Department of Chemistry, HVHP Institute of Post Graduate Studies and Research, Kadi Sarva Vishwavidyalaya, Gandhinagar-382024, India

Corresponding Author(s) : Viralkumar Patel

viral4chem@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 12 (2020): Vol 32 Issue 12, 2020

Abstract

For the simultaneous determination of repaglinide and metformin hydrochloride in bulk, an effective and simple UHPLC method was developed and validated and applied to marketed repaglinide and metformin products. The mobile phase used for chromatographic runs consisted of 30 mM phosphate buffer (pH 3.7) and acetonitrile (20:80, v/v) separation was implemented using isocratic mode on an Agilent Zorbax Eclipse Plus C18 (150 × 4.6 mm, 5 μm) column. Drug peaks were well separated and a 232 nm DAD detector observed them. The method was linear for repaglinide and metformin at the concentration range of 20-100 μg/mL, respectively. The method has been validated with respect to system suitability, specificity, accuracy, precision, robustness and ruggedness according to ICH guidelines. Repaglinide and metformin forced degradation studies were conducted for under acidic, base, neutral (peroxide), thermal and photo conditions.

Keywords

Repaglinide Metformin UHPLC Degradation
Patel, V., Pandya, C., Pandya, A., Patel, Z., & Patel, D. (2020). Development and Validation of Modern UHPLC-DAD Analytical Method for Simultaneous Determination of Repaglinide and Metformin in Pharmaceutical Dosage Forms. Asian Journal of Chemistry, 32(12), 3127–3134. https://doi.org/10.14233/ajchem.2020.22915
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