DEVELOPMENT AND VALIDATION OF NOVEL SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE AND METFORMIN IN BULK AND FIXED DOSAGE FORMS BY AREA UNDER CURVE AND DUAL WAVELENGTH MODE
Objective: Two simple, accurate and reproducible spectrophotometric methods have been developed and validated for simultaneous estimation of metformin (MET) and pioglitazone (PIO) in bulk and tablet dosage forms.
Methods: (1) Area under curve method (Area calculation): The proposed area under the curve method involves measurement of area at selected wavelength ranges. Two wavelength ranges were selected 228-238 nm and 265-275 nm for estimation of MET and PIO respectively. (2) Dual wavelength method: In the dual-wavelength method, two wavelengths were selected for each drug in a way so that the difference in absorbance is zero for another drug. PIO shows equal absorbance at 235 and 266 nm, where the difference in absorbance was measured for determination of MET. Similarly, the difference in absorbance at 216 and 241.5 nm was measured for determination of MET.
Results: Linearity range for MET and PIO is 2-10 Î¼g/ml and 10-50 Î¼g/ml at respective selected wavelengths. Accuracy and precision studies were carried out, and results were satisfactory. The proposed methods have been validated as per ICH guidelines and successfully applied to the estimation of MET and PIO in their combined tablet dosage form.
Conclusion: The developed methods are simple, precise, rugged and economical. The utility of the methods has been demonstrated by analysis of commercially available formulations.Keywords: Metformin, Pioglitazone, Area under curve method, Dual wavelength method
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