Simultaneous Determination of Rosuvastatin and Ezetimibe in pharmaceutical formulations by Stability Indicating Liquid Chromatographic Method

Mathrusri Annapurna Mukthinuthalapati

doi:10.4172/jbb.1000200

Abstract

Rosuvastatin and Ezetimibe are used for the treatment of hyperlipidemia. A stability-indicating RP-HPLC method was developed and validated for the simultaneous determination of Rosuvastatin and Ezetimibe in tablet dosage forms using C 18 column with mobile phase consisting of tetra butyl ammonium hydrogen sulphate-acetonitrile (32:68, v/v) with a flow rate of 1.0 ml/min (UV detection 254 nm). Linearity was observed over the concentration range 0.1-200 μg/ml for both Rosuvastatin (r2=0.9998) and Ezetimibe (r2=0.9998). The LOD and LOQ were found to be 0.0282 μg/ml and 0.0853 μg/m for Rosuvastatin and the LOD and LOQ for Ezetimibe were 0.0297 μg/ml and 0.0901 μg/ml respectively. Rosuvastatin and Ezetimibe were subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, photolysis and thermal degradation. Ezetimibe is highly sensitive towards alkaline conditions. The method was validated as per ICH guidelines. The percentage RSD for intra-day precision was found to be 0.41-0.94 and 0.31-0.59 for Rosuvastatin and Ezetimibe respectively whereas the inter-day precision was found to be 0.68-0.95 and 0.68-1.02 for Rosuvastatin and Ezetimibe respectively. The method is simple, specific, precise, robust and accurate for the simultaneous determination of Rosuvastatin and Ezetimibe in pharmaceutical dosage forms (Tablets).

Highlights

Ezetimibe (EZT) chemically [1] designated as (3R, 4S) - 1 - (4 fluorophenyl) - 3 - [(3S) - 3 - (4 - fluorophenyl) - 3 - hydroxypropyl] - 4 - (4 - hydroxyphenyl) azetidin - 2 - one (Figure 1A)
Rosuvastatin and Ezetimibe were subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, photolysis and thermal degradation
It is used for the treatment of Hyperlipidemia. It reduces levels of low-density lipoprotein, apolipoprotein B and triglycerides in the blood, while increasing levels of high-density lipoprotein in the management of hyper lipidaemias [5]. Various analytical techniques such as micellar liquid chromatography [6], HPLC [7,8,9,10,11,12,13], HPTLC [14,15], densitometric TLC [16], spectrophotometry [17,18,19] and spectrofluorimetry [20] have been developed for the simultaneous determination of Rosuvastatin and Ezetimibe in pharmaceutical formulations

Summary

Introduction

Ezetimibe (EZT) chemically [1] designated as (3R, 4S) - 1 - (4 fluorophenyl) - 3 - [(3S) - 3 - (4 - fluorophenyl) - 3 - hydroxypropyl] - 4 - (4 - hydroxyphenyl) azetidin - 2 - one (Figure 1A). It reduces levels of low-density lipoprotein, apolipoprotein B and triglycerides in the blood, while increasing levels of high-density lipoprotein in the management of hyper lipidaemias [5] Various analytical techniques such as micellar liquid chromatography [6], HPLC [7,8,9,10,11,12,13], HPTLC [14,15], densitometric TLC [16], spectrophotometry [17,18,19] and spectrofluorimetry [20] have been developed for the simultaneous determination of Rosuvastatin and Ezetimibe in pharmaceutical formulations. As no suitable stability indicating method was reported before, a simple, rapid, precise, accurate and robust stability indicating liquid chromatographic method has been developed for the simultaneous determination of Rosuvastatin and Ezetimibe in tablets and validated as per ICH guidelines [22]

Methods

Results

Conclusion