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Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR METFORMIN AND EMPAGLIFLOZINE IN TABLET DOSAGE FORM

Shaik Mahammad Noorulla,* and Sadath Ali

ABSTRACT

The purpose of the investigation was to develop a new HPLC method for simultaneous estimation of Metformin and Empagliflozine in pharmaceutical dosage forms. Chromatography was carried out on an ODS 250mm x 4.6 mm, 5 particle size with a isocratic mobile phase composed of Buffer, Acetonitrile and methanol at a flow rate of 1mL/min. The column temperature was maintained at 30°C and the detection was carried out using a PDA detector at 233 nm. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample and standard stock solutions and robustness were studied as reported in the International Conference on Harmonization guidelines. The retention times for Metformin and Empagliflozine and were 2.211 min and 4.592 min respectively. The percentage recoveries of Metformin and Empagliflozine were 100.39 %and 100.58% respectively. The relative standard deviation for assay of tablets found to be less than 2%. The method is fast, accurate, precise and sensitive hence it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries.

Keywords: Metformin, Empagliflozine, Simultaneous estimation,Stability, ICH guidelines.


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