Novel Analytical Method Development and Validation for Simultaneous Estimation of Metformin Alpha Lipoic Acidin Bulk and Pharmaceutical Dosage Form by UV Spectrometric Method

Author(s): Mayur Patni* and Swati Rawat

A rapid, simple, selective and precise UV-Visible Spectrophotometric simultaneous method (Vierodt’s Method) has been developed for the determination of metformin hydrochloride (MFH) and alphalipoic acid (ALA) in bulk forms and solid dosage formulations. The spectrophotometric detection was as per carried out at an absorp-tion maximum of 232 nm and 334nm for MFH and ALA respectively using phosphate buffer of pH 8 as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector re-sponse for the MFH was linear over the selected concentration range 2 to 12μg/ml with a correlation coefficient of 0.993 and 100-500μg/ml with a correlation coefficient of 0.998. The accuracy was carried out as per recovery study and found between 99.1 % to 100.45% and 99.8% to 101.60% for MFH and ALA respectively. The results demon-strated that the excipients in the tablets did not interfere with the method and can be conveniently employed for routine quality control analysis of MFA and ALA in bulk and formulation.


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