Chemometric-Assisted UV Spectrophotometric Method for Determination of Rosuvastatin Calcium and Ezetimibe in Pharmaceutical Dosage Form

This presented work is based on the application of two multivariate calibration methods for simultaneous UV-VIS spectrophotometric determination of active substances in combined pharmaceutical formulation composed of Rosuvastatin calcium and Ezetimibe. The methods used were Principal Component Regression (PCR) and Partial Least Square (PLS). The Spectra of Rosuvastatin calcium and Ezetimibe were recorded at concentrations within their linear range 5.0-30.0 μg/ml for both drugs. 32 set of mixtures were used for calibration and 09 set of mixtures were used for validation in the wavelength range of 220280nm with the wavelength intervals λ= 0.5 nm in methanol. The methods were validated as per International Conference on HarmonizationQ2 (R1) (ICH) guidelines. These methods were successfully applied for the determination of drugs in a pharmaceutical formulation (tablet) with no interference of the excipient as indicated by the recovery study results. The proposed methods are simple, rapid and can be easily used as an alternative analysis tool in the quality control as well as in process control of drugs and formulation. Amit Gunge, Padmanabh Deshpande* All India Shri Shivaji Memorial Society’s College of Pharmacy, Department of Quality Assurance Techniques, Kennedy Road, Near RTO, Pune-411001 Submission: 25 February 2018 Accepted: 3 March 2018 Published: 31 March 2018 www.ijppr. humanjournals.com Citation: Padmanabh Deshpande et al. Ijppr.Human, 2018; Vol. 11 (4): 248-259. 249 INTRODUCTION Rosuvastatin calcium (RSV), chemically, bis [(E)-7 [4-(4fluorophenyl)-6 isopropyl-2-[methyl (methylsulphonyl) amino] pyrimidin-5-yl] (3R, 5S) -3, 5dihydroxyhept-6-enoic acid],calcium salt [Figure 1(a)]is well-known member of the drug class known as statins, which are used primarily as a lipid-lowering agent that inhibits HMG-CoA reductase enzyme which is found in liver tissue for production of cholesterol [1]. It is official in Indian Pharmacopeia [2]. Ezetimibe (EZT) is 1-(-4-fluorophenyl)-(3S)-hydroxypropyl]-(4S)-(4-hydroxyphenyl)-2azetidinone [Figure 1(b)] is a selective cholesterol absorption inhibitor, which potentially inhibits the absorption of biliary and dietary cholesterol [3]. It is official in Indian Pharmacopeia [4]. Extensive literature survey revealed that methods such as spectrophotometry [5, 6], Highperformance liquid chromatography (HPLC) [7, 8] and High-performance thin layer chromatography (HPTLC) [9] has been reported for the determination of RSV in pharmaceutical formulations either as single drug or in combination with other drugs. Analytical methods reported for determination of EZT includes HPLC [10] and HPTLC [11] methods. Several methods are reported for quantitative determination of RSV and EZT in combination such as UV, RP-HPLC and HPTLC, and [12-16]. Chemometric is the science of extracting information from chemical systems. Multivariate calibration method (e.g., multiple linear regression (MLR), principal component regression (PCR) and partial least squares (PLS) utilizing spectrophotometric data are the important Chemometric approach for determination of mixtures including drugs combination [17]. While working on the development of the simple, accurate and precise method for this combination we came across one recent report for analysis of these drugs by Chemometric analysis using MATLAB software [18]. We have developed a method using Unscrambler X (10.3) software. Compared with a reported method the results were found promising. As there were no reports on a Chemometric analysis of these drugs, the work was undertaken with the aim to develop simple, accurate and reproducible multivariate spectrophotometric methods for simultaneous determination of RSV and ETZ in tablet dosage form. www.ijppr. humanjournals.com Citation: Padmanabh Deshpande et al. Ijppr.Human, 2018; Vol. 11 (4): 248-259. 250 a) b)