Development and Optimization of a Green Stability Indicating HPLC Method for the Determination Metformin HCL and Glibenclamide in their Dosage Form

Document Type : Original Article

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Analytical chemistry, sinai university

Abstract

Green analytical chemistry approach was applied in attempt to develop, optimize and validate a stability indicating RP-HPLC method for the determination of metformin HCL and Glibenclamide in their combined dosage form. The chromatographic separation was performed on C18 column (250×4.6 mm, 5μm) at a λmax of 250 nm with a constant flow rate of 1.00 mL/minute. The isocratic mobile phase consisted of 70.00% organic (ethanol) to 30.00% aqueous 10.00 mM potassium phosphate buffer, pH 3.0 containing 50.00 mM octanesulphonic acid. The two drugs were stressed in acidic, basic, oxidative, and photolytic conditions. The developed method was validated according to ICH guidelines successfully. The detector response was linear in the concentration of 0.50-100.00 μg mL-1 for both drugs. Metformin HCL had detection limit and quantification limit of 0.15 g mL-1 and 0.50 g mL-1, while glibenclamide had detection limit and quantification limit of 0.16 g mL-1 and 0.49 g mL-1, respectively.

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