VALIDATION OF A DEVELOPED ANALYTICAL METHOD FOR DETERMINATION OF NATEGLINIDE AND METFORMIN HCL IN PURE AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC AND ITS DEGRADATION STUDIES
Objective: To develop a versatile analytical method and validate according to ICH guidelines for simultaneous estimation of Nateglinide and Metformin HCl by RP-HPLC in API and in tablet dosage form.
Methods: Analytes, Nateglinide and Metformin are separated and eluted from stationary phase Luna Phenyl Hexyl column (150X4.6mm, 3.5µ) using polar mobile phase composed of Acetonitrile:1% Orthophosphoric acid 30:70 v/v, with flow rate of 1 ml/min for 8 mins at ambient column temperature, at 221nm detection. Acid, base, peroxide, thermal and photolytic induced degradation studies were performed on Nateglinide and Metformin.
Results: Through isocratic flow both Metformin and Nateglinide are detected at retention times of 2.79mins and 5.13mins respectively at 221nm. The linearity and range of analytical method for Nateglinide and Metformin was 0.61-9.15µg/ml and 7.5-75.15µg/ml respectively. The R2 value for Nateglinide was 0.9998 and for Metformin HCl was 0.9991. The LOD and LOQ for Nateglinide was 0.21µg/ml & 0.63µg/ml and for Metformin was 4.8µg/ml & 14.6µg/ml respectively. The %RSD for method precision was found to be 0.22% and 0.64% for both Nateglinide and Metformin respectively. The mean %recovery for Nateglinide and Metformin were 99.88% and 99.21% respectively. The %thermal degradation was identified as 17.7% & 17.5% for Nateglinide and Metformin respectively.
Conclusion: The developed chromatographic (RP-HPLC) method was selective, specific, economic, precise and accurate. Hence it can be one of the preferred analytical method of choice for estimation of Nateglinide and Metformin by RP-HPLC in pure and in tablet dosage form.
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