World Journal of
Pharmaceutical and Life Sciences

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF FENOFIBRATE AND ATORVASTATIN USING HYDROTROPY PHENOMENA

Yadav Nikhil Rakesh* and Dr. N. K. Sahu

ABSTRACT

Aim: The aim of this study is to develop and validate a spectrophotometric method for the simultaneous estimation of fenofibrate and atorvastatin using the hydrotropy phenomena. The objective is to establish a reliable, cost-effective, and environmentally friendly analytical technique for the simultaneous quantification of these two pharmaceutical compounds in a single assay. Objectives: Investigate and identify a suitable hydrotropic agent that enhances the solubility of both fenofibrate and atorvastatin, facilitating their simultaneous analysis. Determine the optimal experimental conditions, including the concentration of the selected hydrotropic agent and the wavelength of maximum absorbance for both fenofibrate and atorvastatin. Method Development: Develop a spectrophotometric method for the simultaneous estimation of fenofibrate and atorvastatin based on the hydrotropy phenomena. Construct calibration curves for fenofibrate and atorvastatin to establish the relationship between concentration and absorbance under the optimized conditions and Validate the developed method according to International Conference on Harmonisation (ICH) guidelines. Conclusion: The developed spectrophotometric method for the simultaneous estimation of fenofibrate and atorvastatin using hydrotropy phenomena is a reliable and accurate analytical tool. The method is simple, cost-effective, and environmentally friendly, making it suitable for routine analysis in pharmaceutical laboratories. The use of hydrotropy not only enhances the solubility of the drugs but also simplifies the analytical procedure. The validation results demonstrate the reliability of the method for quantifying fenofibrate and atorvastatin over a specified concentration range. The method shows good linearity, precision, accuracy, and robustness, meeting the criteria set by regulatory guidelines. This suggests that the developed method can be applied for routine quality control analysis of pharmaceutical formulations containing fenofibrate and atorvastatin.

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