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Abstract
Objective: The objective of the research was the development and validation of a simple, sensitive, accurate, robust, and precise UV-spectroscopic method for the quantitative determination of chlorogenic acid loaded in solid-lipid nanoparticles as per the guidelines of the International Conference on Harmonization.
Methods: The solid-lipid nanoparticles of chlorogenic acid were prepared using the hot melt emulsification method and the high-speed homogenizer method. Glyceryl monostearate was used as a solid lipid, and Tween 80 was used as a surfactant for the preparation of chlorogenic acid-loaded solid lipid nanoparticles. The method was validated in terms of linearity, accuracy, precision, robustness, ruggedness, limit of detection, and limit of quantification. Results: The chlorogenic acid exhibited absorption maxima at the wavelength of 330 nm. The regression equation from the calibration curve was y=0.006x + 0.0193 with a correlation coefficient of 0.9989. The percentage recovery was found to be 99.92, 99.80, and 99.86, respectively (within the acceptable limit of 98-102%), which validated the accuracy of the method. Furthermore, the method exhibited precision, robustness, and ruggedness, as illustrated by a relative standard deviation (RSD) of less than 2%. The limit of detection and limit of quantification were found to be 6.97 and 21.13 μg/ml, respectively. Conclusion: It was concluded that the proposed spectrophotometer analytical method for the determination of Chlorogenic acid was found reliable, accurate, consistent, precise, accurate, and robust. Therefore, the proposed analytical technique could be an integral part of further evaluation and characterization of Chlorogenic acid-solid lipid nanoparticles.