ABSTRACT

The primary goal of this research work was to develop a simple, precise, accurate and specific method for the estimation of Ezetimibe and Fenofibrate in bulk and pharmaceutical dosage form by RP-HPLC. Method development was carried out by HPLC autosampler Schimadzu 2030C 3D Plus with a stationary phase of YMC C8 column(150mmx 4.6mm.ld,3µ,12nm) using mobile phase Acetonitrile: Methanol: Phosphate buffer adjusted to pH 3 with OPA in the ratio 55:15:30v/v/v at a flow rate 1.0mL/min with the injection volume of 20µL and detection is carried out at 255nm. The retention time for Ezetimibe and Fenofibrate was found to be2.458minutes and 7.488minutes. The developed RP-HPLC method was validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, accuracy, precision, linearity range, limit of detection (LOD), limit of quantification (LOQ) and robustness. The % recovery ranged between 98-102% and %RSD was <2%. Linearity was observed in concentration range of 2- 10µg/mL for Ezetimibe and 60-180µg/mL for Fenofibrate with a correlation coefficient 0.9998 for Ezetimibe and 0.999 for Fenofibrate. Hence can be used for routine analysis in industries and institutes. Keywords: Fenofibrate, Ezetimibe, RP-HPLC
Publication date: 01/01/2022

https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_5841.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.1.5841