Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE BY UV SPECTROSCOPY

N. Vani*, Dr. P. Vasanth Kumar, Dr. P. R. Logeshkumar, P. Bhargav Sai, K. Govardhan, J. Jyothi Narasimhudu and P. Yuvaraju

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Abstract

A simple, economic, sensitive, precise and accurate UV spectrophotometric method was developed and validated for quantification of Metformin hydrochloride in bulk and in tablet dosage form. Adequate drug solubility and maximum assay sensitivity was found in 0.01N sodium hydroxide at 233nm. Calibration graph constructed at 233nm was linear in concentration range of 1-25μg/ml with correlation coefficient of 0.9998. The method was validated as per ICH guidelines in terms of linearity (within 1-25μg/ml), accuracy (% recovery), precision (inter-day and intraday), specificity and robustness. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.2226μg/ml and 0.6745μg/ml respectively. Therefore, the proposed method is suitable and can be adopted for the determination of Metformin hydrochloride from pharmaceutical dosage form in routine quality control analysis.

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