Available online at www.derpharmachemica.com Scholars Research Library Der Pharma Chemica, 2014, 6(1):24-30 (http://derpharmachemica.com/archive.html) ISSN 0975-413X CODEN (USA): PCHHAX 24 www.scholarsresearchlibrary.com Method development and statistical comparison for Rosiglitazone and Gliclazide in combined dosage form 1 Lopamudra Adhikari*, 2 Uma S. Mishra and 2 P. N. Murthy 1 School of Pharmaceutical Sciences, S’O’A University, Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha 2 Royal College of Pharmacy and Health Sciences; Andhapasara Road, Berhampur, Odisha _____________________________________________________________________________________________ ABSTRACT 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 C 18 (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. Keywords: Chromatographic method developments, Gliclazide, Rosiglitazone Maleate, Statistical Correlation, Validation. _____________________________________________________________________________________________ INTRODUCTION Rosiglitazone,have a unique mechanism of action, binding to a novel receptor known as the peroxisome proliferators activated receptor γ(PPAR γ).When activated, the receptor binds with response elements on DNA,altering transcription of a variety of genes that regulate carbohydrate and lipid metabolism. The primary effect is decreasing tissue insulin resistance thereby stimulating glucose uptake by peripheral tissues.Secondarily, thiazolidinediones may decrease hepatic glucose production and this may aid in overall blood glucose reduction. These agents do not stimulate the β cells of the pancreas to secrete insulin; however they may enhance the responsiveness and efficacy of the β cells.Prelimnary data suggest that these agents may actually prolong β cell survival and should be considered earlier in therapy. Typical reduction in fasting plasma glucose is 50-60 mg/dl and decrease in HgA1c by 1% to 2% [1-4]. Gliclazide selectively binds to sulfonylurea receptors (SUR-1) on the surface of the pancreatic beta-cells. It was shown to provide cardiovascular protection as it does not bind to sulfonylurea receptors (SUR-2A) in the heart. It