Analytical QbD Approach for Development and Validation of RP-High Performance Liquid Chromatography Method for Determination of Tofisopam in Pure Form and Tablets
Abstract
A novel, simple, optimized reversed-phase chromatography method for assay of Tofisopam in pure and tablet form is developed. The experimental trial was by Box Behnken design using the Design Expert® software 10 version. The attributes selected were peak symmetry, number of theoretical, and peak purity. The predicted data satisfied with actual experimental data. The optimized chromatographic conditions required a quaternary pump with a mobile phase of Water: Acetonitrile 25:75 v/v at 1 mL/min, oven temperature at 25oC at 310 nm using C18(250 × 4.6 mm Id, 5μm) column and PDA detector with a run time of 5 min. The method was validated for linearity, precision, accuracy, and specificity. The method produced a linear response over a concentration range of 4–24 ppm with an overall average accuracy of 99.98%. The method was robust, reproducible, and specific with respect to the retention time of tofisopam.
Keywords:
Analytical quality by design, QbD, Tofisopam, Water, Acetonitrile, Method Development, Validation.DOI
https://doi.org/10.25004/IJPSDR.2020.120210References
Bond A, Lader MA. Comparison of the psychotropic profiles of tofisopam and diazepam.Eur J ClinPharmacol. 1982;22:137-142.
Kokane M, Pananchery J, Jain. A Development and Validation of Spectrophotometric Method for the Determination of Tofisopam in Bulk and Pharmaceutical Formulation. Pharm Anal Acta. 2017;8:551.
Ramadan NK, Osman A. Fooad R, Moustafa A. Development and validation of spectrophotometric and spectrofluorimetric methods for simultaneous determination of tofisopam, JAPS. 2012;2:112-119.
Choi SJ, Kim JS, Park EJ, Sohn DH, Lee HY, Baek SK, Lee HS. Analysis of tofisopam in human serum by column-switching semi-micro high-performance liquid chromatography and evaluation of tofisopam bio equivalency, Biomed Chromatogr. 2002;16:277-281.
Valentik M, Karaffa E, Ladányi L. Investigation of tofizopam impurities using high performance liquid chromatography, Acta Pharm Hung. 1993;63:57-65.
Xiaojuan G. Determination of main component in tofisopam tablet by HPLC, ZhongguoYaofang. 2010;21:3154-3155.
Hu P, Chen Y,Carr G, Guo J, Ye N. Method validation and determination of enantiomers and conformers in tofisopam drug substances and drug products by chiral high-performance liquid chromatography and kinetic and thermodynamic study of the interconversion of the conformers, J Chromatogr A. 2006;1129:47-53.
Cameron MD, Wright J, Black CB, Ye N. In vitro prediction and in vivo verification of enantioselective human tofisopam metabolite profiles., Drug Metab Dispos. 2007;35:1894-1902.
Gaillard Y, Gay-Montchamp JP, Ollagnie M. Simultaneous screening and quantitation of alpidem, zolpidem, buspirone and benzodiazepines by dualchannel gas chromatography using electron-capture and nitrogen-phosphorus detection after solidphase extraction. J. Chromatogr. 1993;622:197-208.
Salvador A, Herbreteau B, Dreux M, Karlsson A, Gyllenhaal O. Chiral supercritical fluid chromatography on porous graphitic carbon using commercial dimethyl β-cyclodextrins as mobile phase additive, J. Chromatography A. 2001;929:101-112.
ICH Harmonized Tripartite guidelines. Validation of Analytical Procedure: Text and Methodology, Q2 (R1), Geneva 2005:1-13.
Published
Abstract Display: 759 
PDF Downloads: 614 
