Open AccessDevelopment and Validation of Stability-Indicating Assay Method by RP-HPLC for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Form
Author(s) -
Awdhut Pimpale,
Rajendra Kakde
Publication year - 2020
Publication title -
journal of drug delivery and therapeutics
Language(s) - English
Resource type - Journals
ISSN - 2250-1177
DOI - 10.22270/jddt.v10i4.4203
Subject(s) - fenofibrate , rosuvastatin calcium , chromatography , calibration curve , chemistry , rosuvastatin , high performance liquid chromatography , dosage form , correlation coefficient , detection limit , pharmacology , mathematics , medicine , statistics
A Simple, precise, and accurate stability-indicating reversed-phase high-performance liquid chromatography method has been established for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined bulk and tablet formulation. The chromatographic separation was performed on reverse phase Princeton (C18) (250 mm x 4.6 mm, 5µ) column with mobile phase as a mixture of water (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio (40:60) v/v at the flow rate 1.0 ml/min. Detection was carried out at wavelength 240 nm. The retention time under the optimized condition of Rosuvastatin calcium and Fenofibrate was found to be 2.485 & 3.905 minutes respectively. The calibration curve was linear in the range of 6-16 µg/ml and 87-232 µg/ml for rosuvastatin calcium and fenofibrate with a correlation coefficient of 0.9999 and 0.9994 respectively. Relative standard deviation values for all key parameters were less than 2.0%. The percentage recovery was found to be 99.66-100.37% and 99.13-100.44% for rosuvastatin calcium and fenofibrate respectively. The developed reversed-phase high-performance liquid chromatography method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of rosuvastatin calcium and fenofibrate in bulk and tablet formulations.
Keywords: Rosuvastatin calcium, Fenofibrate, RP-HPLC, Method validation, ICH guidelines.