Application of Quality by Design for the Optimization of an HPLC Method to Determine Ezetimibe in a Supersaturable Self-Nanoemulsifying Formulation

DASH, RAJENDRA NARAYAN and HABIBUDDIN, MOHAMMED and HUMAIRA, TOUSEEF and Patel, Ayyub Ali (2014) Application of Quality by Design for the Optimization of an HPLC Method to Determine Ezetimibe in a Supersaturable Self-Nanoemulsifying Formulation. Journal of Liquid Chromatography & Related Technologies, 38. pp. 874-885. ISSN 1082-6076

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Official URL | رابط موقع المجلة: http://dx.doi.org/10.1080/10826076.2014.982867

Abstract|ملخص البحث

This paper describes the optimization of an isocratic stability indicating HPLC method for Ezetimibe (EZM). A five factor, three-level Box-Behnken experimental design optimized the method. The responses were (1) retention time, (2) tailing factor, and (3) theoretical plates. The quadratic effect of percentage (v/v) acetonitrile was the most significant (p<0.001) factor to affect retention time and tailing factor, while interactions between percentage (v/v) acetonitrile and buffer pH had the most significant (p<0.05) effect upon theoretical plates. The developed models for each response found to be well predictive bearing an acceptable adjusted correlation coefficient (0.9752 for retention time, 0.8557 for tailing factor, and 0.8336 for theoretical plates). The models were found to be significant (p< 0.001) having a high F value for each response (89.63 for retention time, 14.34 for tailing factor, and 12.27 for theoretical plates). The global desirability found to be 0.93 for the optimum chromatographic condition that achieved at a temperature of 35�2°C using acetonitrile–potassium dihydrogen phosphate (pH 3.5; 20mM) (45:55, v/v). The flow rate and injection volume kept at 0.8mL min�1 and 20 μL, respectively. The optimized chromatographic method subsequently applied to quantify EZM from a novel supersaturable self-nanoemulsifying formulation.

Item Type|تصنيف النتاج العلمي: Article| منشور علمي
Subjects | مجال موضوع النشر: Programming and Computer Operation
Divisions | الكلية: College of Medicine > Clinical Biochemistry
Depositing User: Dr Ayyub Ali Patel
Date Deposited: 10 Jan 2019 06:25
Last Modified: 10 Jan 2019 06:25
URI: http://eprints.kku.edu.sa/id/eprint/4246

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