Simultaneous Spectrophotometric Estimation and Validation of Three Component Tablet Formulation Containing Pioglitazone Hydrochloride, Metformin Hydrochloride and Glibenclamide

Abstract

Simultaneous estimation of active ingredients in multicomponent pharmaceutical products normally requires the use of separation techniques, such as HPLC, HPTLC, or GC, followed by their quantitation. Presented here are two spectrophotometric methods that do not require prior separation for simultaneous estimation of three drugs—pioglitazone HCl, metformin HCl, and glibenclamid—in a tablet formulation. Shimadzu UV 1700, capable of multicomponent analysis, was used for quantitation. In method I, absorbance of the sample solution was measured at 285 nm and 300 nm for the estimation of pioglitazone HCl and glibenclaimide, and at 237 nm for estimation of metformin hydrochloride, respectively. Method II is based on a multiwavelength spectroscopic method. Recording the absorbances of standard solutions at 237 nm, 268 nm, 280 nm, and 300 nm were processed by means of statistical calculations and results of the sample solution were obtained. All three drugs obey Beer's law in the concentration ranges used for the methods. The result of the analysis for both methods were tested and validated for various parameters according to ICH guidelines. The utility of the developed methods has been demonstrated by an analysis of commercial formulation containing all the three drugs.

Keywords:

• Absorbance ratio method
• glibenclamide
• metformin HCl
• multi-wavelength spectroscopy
• pioglitazone HCl

The authors are thankful to Ranbaxy Laboratories Pvt. Ltd. Dewas, M.P., India and Nicholas Piramal India Ltd., Pithampur, Dhar, M.P., India for providing gift samples of MET, PIO, and GLI respectively. The authors are also thankful to Mr. Suresh Parajapat, Laboratory Technician, School of Pharmacy, for technical assistance. One of the authors, Mr. P.K. Chaturvedi, is thankful to the All India Council for Technical Education (AICTE) for providing junior research fellowship.

Notes

^a Value for drug content (%) is the mean of five estimations, S.D.: Standard deviation, R.S.D: Relative standard deviation, S.E.: Standard error, Method-I: Three wavelength spectrophotometry, Method-II: Multi-wavelength spectroscopy.

% recovery is the mean of three estimations, Method I: Three wavelength spectrophotometry, Method II: Multi-wavelength spectroscopy, COV: Coefficient of variance.

^a Mean of five determinations, COV: Coefficient of variance, LOD: Least of detection, and LOQ: Least of quantitation. Method I: Three wavelength spectroscopy, Method II : Multi-wavelength spectroscopy.