Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF ANTI-DIABETIC DRUGS

Amol V. Sawale

ABSTRACT

Objective: the objective of this study was to develop a simple, efficient, specific, precise and accurate RP-HPLC method for Metformin Hydrochloride and Gliclazide in combined dosage form. Method: The separation method was carried out using reverse phase C18 column(Cosmosil) (150×4.6mm, 5.0μ);the mobile phase used was a mixture of Methanol + Water (0.1% OPA) (60+40% v/v) pH 4.2, with flow rate 0.7ml/min, and eluents were monitored at 233nm using UV spectroscopic detector. Results: With the optimized method, the retention times of Metformin Hcl and Gliclazide were found to be 2.2833min and 5.6667min with theoretical plate count as per ICH limits. This method showed good linearity in concentration range of 50-250μg/ml for Metformin HCL and 5-25 μg/ml for Gliclazide with Regression Coefficient (R2) of 0.9995 and 0.9993 respectively. The limits of detection and limits of Quantitation values were found to be within limit of standard. The method was found to be accurate, precise, robust, stable and specific of Metformin and Gliclazide were found to melt in the range of 123-1260C and 181-1820C respectively freely soluble in Acetonitrile, Methanol. λ max of Metformin and Gliclazide was found to be 233 nm respectively. Conclusion: The developed method was validated as per the ICH guidelines and hence can be successfully applied to the estimation of Metformin Hcl and Gliclazide in Pharmaceutical tablet dosage form.

Keywords: Metformin Hcl, Gliclazide Simultaneous estimation, Reverse phase HPLC, Validation.


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