Bioanalytical Method Development and Validation of Metformin HCl and Repaglinide in Bulk and Combined Dosage Form in Human Plasma by using UV Spectroscopy

Author: K. Bhavya Sri, Samreen Begum, D. Suchitra, V. Narmada and M. Sumakanth

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Abstract

A simple, rapid, accurate, precise, and robust method has been developed and validated for estimating Repaglinide and Metformin HCl in human plasma. Method: The Protein precipitation method was used for obtaining metformin and repaglinide from serum, using ethyl acetate and 0.1N hydrochloric acid. The solvent used was Acetonitrile: water (70:30). The isosbestic point was found to be at 245.5 nm. The challenges in the study were the availability of serum and extraction of drug from the serum. Results: Extraction efficiency for Metformin HCl and Repaglinide was found to be 95.4% and 96.8% respectively. The precision was in terms of %CV which was found to be less than 2%. LLOQ and ULOQ were found to be 1.66:0.06 and 12.5:0.5 respectively. All the validation parameters like linearity, precision, accuracy, LLOQ, ULOQ, LOD, and LOQ were performed according to ICH guideline M 10. % Assay was done by using the simultaneous equation method. All the parameters were found to be within the limits. The proposed UV method can be successfully applied for the estimation of metformin HCl and Repaglinide in human plasma. As diabetic patients are increasing day by day so there is a need to develop a method for simultaneously estimating two drugs i.e., Metformin HCl and Repaglinide in human plasma. The method has been done in UV hence the method is economic and the method can be further extended to HPLC, LC-MS, 2D-LC, and further hyphenated techniques.

Keywords

Bioanalytical method development, Extraction, Human plasma, Metformin HCl, Repaglinide, UV-Visible Spectrophotometer

Conclusion

A simple, economic, rapid, precise, and accurate Spectrophotometric method has been developed and validated for quantitative estimation of Metformin HCl and Repaglinide (500:2) in human plasma. Extraction of drugs from plasma has been done by protein precipitation. All the validation parameters like Specificity, LLOQ, ULOQ, precision, accuracy, LOQ, and LOD have been performed according to ICH guidelines Q10 M. All validation parameters were confirmed to be within their respective limitations. Hence the developed method can be successfully used for quantitative estimation of metformin HCl and Repaglinide in combined tablet dosage form in human plasma using UV-spectroscopy.

References

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How to cite this article

K. Bhavya Sri, Samreen Begum, D. Suchitra, V. Narmada and M. Sumakanth (2023). Bioanalytical Method Development and Validation of Metformin HCl and Repaglinide in Bulk and Combined Dosage Form in Human Plasma by using UV Spectroscopy. Biological Forum – An International Journal, 15(3): 640-644.