Abstract
The aim of the present study was to develop a simple isocratic reverse phase-high performance liquid chromatography (RP-HPLC) method and validate for the determination of fenofibrate in tablet dosage forms. RP-HPLC method was developed using Hi Q Sil C18 (250 cm × 4.6 mm, 5 μm) and mobile phase comprising 1 mM ammonium acetate buffer: Acetonitrile (10:90 v/v) at a flow rate of 1.0 mL/min. The detection was carried out at 290 nm. The retention time was found to be 6.15 ± 0.03 min. Validation of the method was performed for precision, accuracy, linearity, robustness, specificity and sensitivity to conform to the International Conference on Harmonization (ICH) guidelines. The data of linear regression analysis indicated a good linear response in the concentration range of 5 μg/mL–30 μg/mL with correlation co-efficient (R2) of 0.997. The developed method was found to be simple, sensitive, accurate and repeatable for assay of tablets of fenofibrate prepared using crystallo-co-agglomerates of the drug.
Highlights
Fenofibrate, 1-methylethyl 2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoate, is used as antihyperlipidemic drug
The present study describes the development and validation of a simple, specific, accurate and precise reverse phase-high performance liquid chromatography (RP-high performance liquid chromatography (HPLC)) method for determination of fenofibrate in tablet dosage forms, validated according to the International Conference on Harmonization (ICH) guidelines (ICH 2005)
Sodium lauryl sulphate (SLS), starch, PVP K-30, lactose used were purchased from Loba Chemie (Mumbai, India)
Summary
The aim of the present study was to develop a simple isocratic reverse phase-high performance liquid chromatography (RP-HPLC) method and validate for the determination of fenofibrate in tablet dosage forms
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