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Received: 20 November 2017; Accepted: 8 December 2017; Published: 19 December 2017
Abstract: The aim of this study was to develop and validate a fast and simple reversed-phase HPLC method for simultaneous determination of four cardiovascular agents-atorvastatin, simvastatin, telmisartan and irbesartan in bulk drugs and tablet oral dosage forms. The chromatographic separation was accomplished by using Symmetry C18 column (75 mm × 4.6 mm; 3.5 μ) with a mobile phase consisting of ammonium acetate buffer (10 mM; pH 4.0) and acetonitrile in a ratio 40:60 v/v. Flow rate was maintained at 1 mL/min up to 3.5 min, and then suddenly changed to 2 mL/min till the end of the run (7.5 min). The data was acquired using ultraviolet detector monitored at 220 nm. The method was validated for linearity, precision, accuracy and specificity. The developed method has shown excellent linearity (R2 > 0.999) over the concentration range of 1-16 μg/mL. The limits of detection (LODs) and limits of quantification (LOQs) were in the range of 0.189-0.190 and 0.603-0.630 μg/mL, respectively. Inter-day and intra-day accuracy and precision data were recorded in the acceptable limits. The new method has successfully been applied for quantification of all four drugs in their tablet dosage forms with percent recovery within 100 ± 2%.
Keywords: reversed-phase HPLC; atorvastatin; simvastatin; telmisartan; irbesartan
(ProQuest: ... denotes formulae omitted.)
1. Introduction
Atorvastatin (ATV) is chemically (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5- propan-2-ylpyrrol-1-yl] 3,5-dihydroxyheptanoic acid (Figure 1A), while simvastatin (SMV) is [(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8ahexahydronaphthalen- 1-yl]2,2-dimethylbutanoate (Figure 1B). Both ATV and SMV belong to the statins, which is a class of drugs that are used to lower blood cholesterol and triglyceride levels in the patients with cardiovascular complications and those at high risk for the development of atherosclerosis [1-3]. Statins exert their anti-hyperlipidemic effects through competitive inhibition of 3-hydroxy-3-methyl glutaryl coenzyme-A (HMG-CoA) reductase and hence inhibit a rate limiting step in biosynthesis of cholesterol. As a consequence, these drugs lower the risk of heart attack, stroke and related cardiac complications in individuals with coronary heart disease, type 2 diabetes and other cardiovascular conditions [4-6]. In addition to lipid lowering effect, these drugs also have been reported to possess anticancer [7,8], immunomodulatory [9], anti-inflammatory [9], anti-oxidant [10], anti-malarial [11] and antifungal [12] activities.
Telmisartan (TLN) is chemically, 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol- 1-yl]methyl]phenyl]benzoic acid (Figure 1C) and...