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Using Design Space and Response Surface Methodology for developing a liquid chromatography method for simultaneous determination of five statins in pharmaceutical form

100%

Belmir H. , Abourriche A. , Bennamara A. , Saffaj T. , Ihssane B.

Acta Chromatographica

2021

tom Vol. 33, no. 4

345--353

This study describes the development of a method allowing the simultaneous separation and quantification of five statins by High performance liquid chromatography/Diode Array Detector (HPLC/ DAD). Optimization was accomplished using chemometric tools such as the Design Space (DS) and Response Surface Methodology (RSM). Central Composite Design (CCD) and DS were applied for the optimization of the chromatographic procedure as well as the robustness of the chromatographic method by taking the ratio of the percentage of acetonitrile (%ACN) Buffer solution, the pH and the mobile phase flow rate as critical parameters. Satisfactory results were obtained after the optimization phase with a percentage of mobile phase equal to 46.19%, a pH of 4.16 and the flow rate is 1.4 mL min1 by setting the resolution limits above 6, and the target retention time of 20 min. Using the DS and CCD approach, we have developed a robust and reliable procedure for the simultaneous and accurate separation and quantification of the five statins.

Optimization and validation of a new high-performance liquid chromatographic method for analysis of acetazolamide in tablets using Box-Behnken statistical experiment design

86%

Ihssane B. , Charrouf M. , Abourriche A. , Abboud Y. , Bouabidi A. , Bennamara A. , Saffaj T.

Acta Chromatographica

2011

tom Vol. 23, no. 1

41--57

This paper describes the optimization and validation of an analytical method for HPLC analysis of acetazolamide in tablets using Box-Behnken design. This multivariate approach enables substantial improvement of chromatographic performance using fewer experiments, without additional cost of columns or other equipment. By use of quadratic regression analysis, equations were developed describing the behavior of the response as simultaneous functions of the selected independent variables. Accordingly, the optimum conditions were determined. For quality-control samples these were use of a C18 column with acetonitrile-phosphoric acid buffer solution (0.01 M, pH 7.1) 15:85 (ν/ν) as mobile phase at a flow rate of 1.0 mL min-1 Diode-array detection was performed at 266 nm. The method was validated, in accordance with ICH guidelines, for accuracy, precision (intra-day and inter-day coefficient of variation <2.0%), selectivity, and linearity (R2 = 0.9993) over the concentration range 10–300 μg mL. -1 The method is simple, rapid, sensitive, and accurate and the retention time is less than 4 min. The method is therefore suitable for routine quality-control monitoring of acetazolamide in tablets.