A SIMPLE HPLC-UV METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF DEXIBUPROFEN APPLIED IN BIOEQUIVALENCE STUDY

• Published in: Journal of liquid chromatography & related technologies Vol. 35; no. 13; pp. 1798 - 1811
• Main Authors: Loya, Punnamchand, Saraf, Madhusudan N.
• Format: Journal Article
• Language: English
• Published: Colchester Taylor & Francis Group 01.08.2012; Taylor & Francis; Taylor & Francis Ltd
• Subjects: Analysis; bioequivalence study; Biological and medical sciences; dexibuprofen; General pharmacology; HPLC-UV; human plasma; Liquid chromatography; Medical sciences; Pharmacokinetics; Pharmacology. Drug treatments; rapid; Retention time; simple; Ultraviolet radiation; Variance analysis; Human; Validation; Biological fluid; Chemical analysis; Bioequivalence; Healthy subject; Oral administration; HPLC chromatography; rapid; Dexibuprofen; simple; Blood; Blood plasma; Reversed phase chromatography; bioequivalence study; Ultraviolet detector; Pharmacokinetics; HPLC-UV; human plasma; Quantitative analysis
• ISSN: 1082-6076; 1520-572X
• DOI: 10.1080/10826076.2011.627602

A simple, rapid, and sensitive HPLC with UV detection was developed and validated for the determination of dexibuprofen in human plasma. The method involves extracting dexibuprofen with acetonitrile. Chromatographic separation was carried out on a C18 column using mixture of acetonitrile:methanol:potassium dihydrogen phosphate as mobile phase with UV detection at 222 nm. The retention time of dexibuprofen was 4.720 ± 0.3 min. The method was validated for selectivity, linearity, and range; intra-day and inter-day accuracy; and precision and stability. The developed and validated method was applied to a single oral dose of 400 mg dexibuprofen reference formulations (IBUSOFT 400 tablets manufactured by Emcure Pharmaceuticals Ltd, Pune, India) or test formulations (Medley Pharmaceuticals Ltd, Mumbai, India) that were administered to Indian healthy human male subjects. Serial blood samples were collected for 12 hr after administration of formulations. Pharmacokinetic parameters were determined for both the formulations. C max , AUC 0-t and AUC 0-inf , were evaluated for bioequivalence after log-transformation of data using ANOVA with a 90% confidence interval level. All of the tested parameters were within the acceptable range of 80-125%. The present method is simple and readily applicable to pharmacokinetic and routine bioequivalence studies of these compounds with an acceptable sensitivity.