Method development and statistical comparison for Rosiglitazone and Gliclazide in combined dosage form

Lopamudra Adhikari; Uma S. Mishra; P. N. Murthy

Abstract

Method development and statistical comparison for Rosiglitazone and Gliclazide in combined dosage form

Author(s): Lopamudra Adhikari*, Uma S. Mishra and P. N. Murthy

A rapid reverse phase high performance liquid chromatography method has been developed and validated for the determination of Rosiglitazone maleate and Gliclazide simultaneously in tablets. Two methods were developed and individually validated and a comparative aspect has been shown between the methods. Isocratic chromatography was performed on a Xterra C18 (250X4.6mm) with acetonotrile: water (1.5%HCl) in the ratio of 40:60 as a mobile phase for Method I and Acetonitrile: Ammonium acetate buffer of pH=4.5 (55:45) as the mobile phase for Method II at a flow rate of 1.0 ml min-1 and the detection was monitored out by photodiode array detector at 235 nm. Retention time was found out to be 1.98min and 3.02min for Method I and 6.4min and 7.4min for Method II.Good linearity was demonstrated in the range of 5-250 μg/ml and 10-240 μg/ml for Rosiglitazone in Method I and Method II respectively and 2-300 μg/ml and 2-160 μg/ml for Gliclazide in Method I and Method II respectively (r~0.9999 in each case). Various chromatographic parameters including precision, accuracy, system suitability, specificity, LOD, LOQ and robustness have been evaluated. The proposed method was statistically evaluated and a statistical correlation has been shown and can be applied for routine quality control analysis of Rosiglitazone maleate and Gliclazide.

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