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Hcl And Glimepiride Report

794 Words4 Pages

ABSTRACT A force degradation profile of Metformin Hcl & Glimepiride in combine tablet dosage form on RP-HPLC was developed using Grace RP-C18 (4.6 x 150 mm, 5 μm) in an gradient mode with mobile phase comprising of Acetonitrile: Dihydrogen Pott.Phosphate (pH 2.5 using 0.1% OPA) The flow rate was 0.7 mL/ min and effluent was monitored at 242 nm.. The retention times were found to be 2.06 min for MET and 5.80 min for GLIM. The assay shows a linear dynamic range of 250- 1250 μg/mL for MET and 1.0-5.0 μg/mL for GLIM. The calibration curves were linear (r2 = 0.999 for MET and r2 = 0.998 for GLIM) over the entire linear range. Mean % recovery was found to be 99.80 % for MET and 98.93 % for GLIM with % RSD was NMT 2 for both estimations which fully agrees with system suitability which is in good agreement with labeled amount of formulation. The % RSD for Intra- Day & Inter-Day Precision was NMT than 2 for both the drugs. The developed method was validated as per ICH guidelines Introduction HPLC is a physical …show more content…

The developed RP-HPLC method is very simple involving no complicated sample preparations. Therefore the developed RP-HPLC method can be applied for routine quantitative and qualitative analysis of MET and GLIM in bulk and pharmaceutical formulations like tablets. The developed RP-HPLC method was validated as per the ICH guidelines. References: 1. Gumieniczek A. “Stability-indicating validated HPLC method for simultaneous determination of oral antidiabetic drugs from thiazolidinedione and sulfonylurea groups in combined dosage forms”, J AOAC Int. 2010 Jul-Aug , vol 93(4): page no:1086-92 2. International Conferences on Harmonization Q2 (R1) Validation of Analytical Procedures: text and methodology,

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