Novel Method Development for Metformin, Ivabradine, Metoprolol and Ertugliflozin and its Validation in API and Pharmaceutical Dosage Form by RPHPLC Method

Novel Method Development for Metformin, Ivabradine, Metoprolol and Ertugliflozin and its Validation in API and Pharmaceutical Dosage Form by RPHPLC Method G. Haritha Research Scholar, Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India. Vijey Aanandhi M Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India. P. Shanmugasundaram Director, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, Tamil Nadu, India.

Present investigation is based upon a new method development and validation for the simultaneous estimation of drugs comes under the classification of anti-hypertensive and anti-diabetic. For the proposed method metformin, ivabradine, metoprolol and ertugliflozin drugs were selected. The chromatographic separation was achieved by using mobile phase 0.01N potassium dihydrogen ortho phosphate buffer and acetonitrile (50:50) ratio and stationary phase of kromasil C18(250×4.6mm, 5µm) column. The retention times for metformin, ivabradine, metoprolol and ertugliflozin were found to be 2.560min, 3.116 min, 3.473 min and 5.196 min respectively. The developed method shows that all the drugs were clearly separated among each other with the system suitability. The developed method was further validated as per ICH guidelines Q2R1. It was found the method was accurate, presice with good linearity. Hence this method can be used for the routine analysis of these drugs in biological sample.
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