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METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCl AND MYO-INOSITOL IN PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC
Dr. P. Nagaraju*, G. Parimala Devi
A simple, sensitive, specific, accurate reversed phase high performance liquid chromatographic method was developed for the simultaneous estimation of Metformin HCl and Myo-Inositol in pharmaceutical dosage form. RP-HPLC separation was achieved on an Enable C-18 250mm x 4.6mm, 5?m column. The mobile phase composed of Acetonitrile: Water (70:30 % v/v) [HPLC Grade] at flow rate 1ml/min with UV detection at 228 nm. The retention times of Metformin HCl and Myo-Inositol were found to be 2.752 min and 3.626 min respectively. Linearity was established for Metformin HCl and Myo-Inositol in the range of 25-150µg/ml and 60-360µg/ml respectively. System precision and method precision was found to be within the limits of the acceptance criteria. Relative standard deviation of Metformin HCl and MyoInositol for System precision was found to be 0.22 and 0.02 respectively and method precision was found to be 0.23 and 0.257 respectively. The percentage recoveries for Metformin HCl and Myo-Inositol were found to be in the range of 100.15-102.0% and 99.75-100.04% respectively. The limit of detection was 0.17µg/ml and 1.08µg/ml respectively. The limit of quantification was 0.52µg/ml and 0.37µg/ml respectively and the method was found to be specific. This method can be successfully employed for simultaneous quantitative analysis of Metformin HCl and Myo-Inositol in bulk drugs and formulations. The results indicate that there is no interference from excipients for the proposed method, thus making the method simpler, less time consuming and suitable for routine estimation of Metformin HCl and MyoInositol tablet formulation.[Full Text Article]