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Published on:Oct 2016
Indian Journal of Pharmaceutical Education and Research, 2016; 50(4):563-573
Original Article | doi:10.5530/ijper.50.4.8

A Novel QbD Based SPE-HPLC Bio-analytical Method for Edaravone in Rat Plasma, A Pharmacokinetic Study


Authors and affiliation (s):

Suraj Fanse1, Madhuri Baghel1, Prachi Bhamre1, Sadhana Rajput1*

1Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Building, Donor’s Plaza, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara, Gujarat, INDIA.

Abstract:

A simple, sensitive and feasible Quality by design based RP-HPLC bioanalytical method was developed and validated for Edaravone. Plackett burman design and 3¥3 full factorial designs were utilized for factor screening and optimization respectively, to achieve well resolved asymmetric peaks of both internal standard and drug with good theoretical plates. The optimized chromatographic peak was obtained with mobile phase composition of 10 mM ammonium acetate buffer (pH 6) and acetonitrile (60:40, v/v) at a flow rate of 1.0 ml/m and detection wavelength of 243 nm using Kromasil C18 (250 mm × 4.6 mm; 5 μm) column. Non normality, skewness or outliers did not exist as demonstrated by residual plot. To eliminate the possible interferences in the biological matrices, a new solid-phase extraction method using STRATA X C18 Phenomenex cartridges was developed and evaluated. The method was validated as per USFDA guideline. The developed method was efficiently applied to pharmacokinetic study in rat plasma.

Keywords: QbD, SPE, Bioanalytical method, Edaravone, Carbamazepine.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs