Published Paper Details:

This study includes development of RP-HPLC method for simultaneous estimation of Metformin hydrochloride and Nateglinide. The developed method was validated as per ICH guidelines in terms of specificity, Accuracy, Precision, Linearity, LOD, LOQ, Ruggedness and Robustness. The inter-day and intra-day precision results were good enough to indicate that the proposed method was precise and reproducible. The assay experiment showed that the contents of Metformin HCI and Nateglinide estimated in the tablet dosage form were free from the interference of excipients, which indicate that developed method was specific. Recovery of standard drugs added was found to be 100.07-100.82% for Metformin HCI and 101.0-102.22% for Nateglinide indicating that the proposed method was accurate. A good linear relationship was observed for Metformin HCI and Nateglinide in the concentration ranges of 10-80�g/ml and 10-80�g/ml respectively. The correlation coefficient for Metformin HCI was found to be 0.9991 and for Nateglinide was 0.9997. The LOD were 0.710 and 0.380�g/ml for Metformin HCI and Nateglinide, respectively. For Metformin HCI and Nateglinide LOQ were found to be 2.15 and 1.16�g/ml respectively. This demonstrated that developed RP-HPLC method was simple, linear, precise, accurate, robust and rugged could be conveniently adopted for the routine quality control analysis of Metformin HCI and Nateglinide simultaneously, from its pharmaceutical formulation and bulk drug.