Abstract
SIMULTANEOUS ESTIMATION OF METFORMIN AND PIOGLITAZONE BY RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF BULK AND PHARMACEUTICAL DOSAGEFORM
S. Srinivasa Rao*, Rathnakar Nathi, B.Anusha, B.Saroja, B.Shrija, K.Manisha
ABSTRACT
A specific, accurate, precise and reproducible HPLC method has been developed and subsequently validated for Metformin and Pioglitazone in commercial tablets. The proposed HPLC method utilizes Agilent eclipse XDB C18 column (150 mm - 4.6 mm i.e., 5 ?m) and mobile phase consisting of Acetonitrile: NaH2PO4 pH 5.00 (50:50 v/v) at a flow rate of 1.0 mL/min. Quantitation was achieved with UV detection at 232 nm and 246 nm based on peak area with linear calibration curves at concentration range 50-800 ?g/mL and 7.5-120 ?g/mL for Metformin and Pioglitazone (R2> 0.999 and 1.0). The method was validated in terms of accuracy (% recovery 99.6% and 99.5), precision (%RSD 0.04 and 0.05), linearity, limits of detection (4.1 ng/ml), limits of quantitation (12.6ng/ml), assay (100.5%), and robustness. This method has been successively applied to pharmaceutical formulation.
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