An improved HPLC method with the aid of a chemometric protocol: Simultaneous analysis of amlodipine and atorvastatin in pharmaceutical formulations

Abstract

Statistical experimental design and Derringer's desirability function were applied to develop an improved RP-HPLC method for the simultaneous analysis of amlodipine and atorvastatin in pharmaceutical formulations. Four independent factors were considered: acetonitrile content in the mobile phase; buffer pH; buffer concentration; and flow rate. The preliminary screening step was carried out, according to a 2(4-1) fractional factorial design, to identify the significant factors affecting the analysis time response. Then central composite design was applied for a response surface study, in order to examine in depth the effects of the most important factors. Subsequently, Derringer's desirability function was employed to simultaneously optimize the six responses: retention factor of first peak; two resolutions; and three retention times, each having a different target. This procedure allowed deduction of two separate optimum conditions, intended for the analysis of quality control and plasma samples, within the experimental domain. The predicted optimum for the quality control samples was: methanol-acetonitrile-15 mM K(2)HPO(4) buffer (pH 5.33) (10:42.08:47.92, v/v/v) as the mobile phase and 1.12 mL/min as the flow rate. The method using this optimized condition showed higher sensitivity and shorter analysis time than the previously published reports. The optimized assay condition was validated according to International Conference on Harmonization guidelines.

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

“…HPLC methods were published for simultaneous determination of atorvastatin in combination with amlodipin [49], fenofibrate [50], ezetimibe [51] and ramiprile [47,52]. An improved HPLC method, with higher sensitivity and shorter analysis time using a chemometric protocol (statistical experimental design and Derringer's desirability function) was developed for simultaneous analysis of amlodipine and atorvastatin in pharmaceutical formulations [53]. Three HPLC methods have been published for analysis of atorvastatin and acetylsalicylic acid in combination with clopidogrel [54] and ramipril [55].…”

Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy

“…Since HPLC utilizes a wide selection of several chromatographic factors, viz., the type and composition of the organic phase, column temperature, flow rate, buffer molarity, pH, type of the stationary phase, etc., optimization of the experimental conditions is a complicated process. To achieve this objective, any one of the chemometric methods which includes the overlapping resolution maps (Lews et al, 1996), factorial design (Valliappan et al, 2002) and response surface methodology (Myers and Montgomery, 1995;Sivakumar et al, 2007Sivakumar et al, , 2007aSivakumar et al, ,b, 2008 can be applied. In general, the chemometrics can be used to accomplish a variety of goals in chromatography laboratory: (i) speeding methods development, (ii) make better use of chromatographic data and (iii) explain the chromatographic process (Matthijs et al, 2004).This kind of knowledge provides important clues in the attainment of optimum experimental conditions in the development of chromatography methods (Morgan, 1991).The best experimental design approach for the purpose of modeling and optimization is the response surface design (Myers and Montgomery, 1995).…”

“…We have recently employed the same MCDM approach (Derringer's desirability function) for the development and optimization of a HPLC method for the simultaneous estimation of pantoprazole and domperidone (Sivakumar et al, 2007b), amlodipine and atorvastatin (Sivakumar et al, 2007) in quality control and plasma samples.…”

HPLC–MS–MS for the Simultaneous Determination of Atorvastatin and Amlodipine in Plasma of Hypertensive Patients

“…Amlodipine is a calcium channel antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscles and cardiac muscles and has been used in the treatment of hypertension and angina pectoris [3]. It undergoes oxidative metabolism of the dihydropyridine to a pyridine analog by CYP3A4 [4].…”