Design Expert-supported Method Development and Validation of Cilostazol in Pharmaceutical Formulation Using High-performance Liquid Chromatography

被引:0
|
作者
Nalini, Calamur Nagarajan [1 ]
Afreen, Afnaan [1 ]
Satapathy, Bhagyalata [1 ]
机构
[1] Tamil Nadu Dr MGR Med Univ, CL Baid Metha Coll Pharm, Dept Pharmaceut Anal, Chennai 600097, India
关键词
Quality by design (QBD); response surface methods (RSM); box behnken design; design expert 11; cilostazol; ICH Q2A guidelines; HPLC METHOD DEVELOPMENT; HUMAN PLASMA; RAT PLASMA; QUANTITATIVE-DETERMINATION; ANALYTICAL QUALITY; MASS-SPECTROMETRY; BULK DRUG; METABOLITES; 3,4-DEHYDRO-CILOSTAZOL;
D O I
10.2174/0115734129346572241125111122
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background Developing a simple HPLC method requires an expansive array of literary evidence and experimental routines to perceive the nature of a drug and eventually determine the specific mobile phase and column to be used for attaining better results.Objectives The study aimed to develop and optimize a new, simplified, robust, and sensitive method for the determination of cilostazol in tablets by high-performance liquid chromatography using a Box Behnken design.Methods The chromatographic separation was carried out on an ODS C18 (4.6 X 250mm and 5 mu m) column with acetonitrile and methanol (25:75% v/v) at an effluent flow rate of 1 mL/min and detected at 257 nm.Results The method was found to be linear in the concentration range of 10-50 mu g/mL, and the correlation coefficient was found to be 0.988, and the recovery of cilostazol was 98.16%. The optimized method validated as per ICH Q2A guidelines was found to be accurate, precise, robust, and stable.Conclusion This research thus throws light on the implementation of statistical multivariate analysis techniques used for drug analysis.
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页码:1033 / 1042
页数:10
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