Wed, 22 Nov 2017

Validated Stability-Indicating Isocratic RP-HPLC Method of Determination of Rosuvastatin calcium and Fenofibrate in Bulk and in Solid dosage by Vieordt’s method

Rekha Rajeevkumar *1, Dr. P.Rajeev kuma2

School of Pharmacy, PRIST University, Manamai-Nallur, ECR, Near Mahabalipuram, Chennai, Tamilnadu -603102.


ABSTRACT

A modest, fast, precise, and accurate, stability-indicating reversed phase high performance liquid chromatographic method was developed and validated for vierodt’s method of analysis  of rosuvastatin calcium(RSTC) and fenofibrate (FBT). The  volume of injection sample was 20 μl and the quantification was obtained by UV-VISIBLE detector at 240nm.The chromatographic separation was achieved on X bridge C18, 250 x 4.6 mm, 5 µm particle column, by an gradient mobile phase comprising of acetonitrile: 10 mM potassium dihydrogen phosphate buffer solutions of pH 5.5 in the ratio of 90:10 v/v at a flow rate of 1.5 ml/ min. The retention times for RSTC and FBT were found to be 4.35min and 7.75 min, respectively. The drugs were shown to thermal, photolytic, hydrolytic, and oxidative stress conditions and the stressed samples were evaluated by the suggested method. Validation of the method was approved as per International Conference on Harmonization (ICH) guidelines. Linearity was accepted for RSTC and FBT in the range of 0.040-0.120 mg/ ml and 0.016-0.048 mg/ ml, respectively. The limits of detection were 0.02 μg/ ml and 0.05 μg/ ml, respectively and the LOQ value 0.1 μg/ ml and 0.09 μg/ ml, for RSTC and FBT, respectively. The developed method was profound to be accurate, precise and stability-indicating as no interfering peaks of degradants and excipients were identified. The suggested method is hence appropriate for application in quality-control laboratories for quantitative determination of both the drugs individually and in combination, since it is simple and rapid with good accuracy and precision.

Keywords: Rosuvastatin calcium (RSTC), Fenofibrate (FBT), reversed-phase HPLC, stability-indicating assay, forced degradation studies, method validation


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