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Development, Validation and Pharmacokinetic Application of a Simple and Robust RP-HPLC Method for Quantitation of Raloxifene in Rat Plasma

Mahmood, Syed and Sengupta, Pinaki and Mandal, Uttam K. and Chatterjee, Bappaditya and Taher, Muhammad (2017) Development, Validation and Pharmacokinetic Application of a Simple and Robust RP-HPLC Method for Quantitation of Raloxifene in Rat Plasma. Latin American Journal of Pharmacy, 36 (9). pp. 1901-1908. ISSN 2362-3853

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Abstract

SUMMARY. A simple and sensitive HPLC method has been developed and validated for the quantification of raloxifene in rat plasma. Liquid- liquid extraction procedure was employed for extracting raloxifene from rat plasma sample. Separation of raloxifene was achieved through a RP- C18 column with a mobile phase consisted of phosphate buffer and acetonitrile (66:34 %, v/v). The method was validated for specificity, selectivity, sensitivity, linearity, accuracy, precision, recovery and stability parameters. A linear response (R2 value 0.9991) was found over the calibration range of 50 to 500 ng/mL. The accuracy for intra and inter day run varied between 86.73 to 102.30 % and 91.11 to 95.56%, respectively. The corresponding precision (% CV) were within 0.82 to 9.43% and 6.23 to 8.33%. The method was also found to be specific and stable. The applicability of the method was established through a single dose oral pharmacokinetic study of raloxifene in rat.

Item Type: Article
Additional Information: Indexed in Scopus and ISI
Uncontrolled Keywords: bioanalytical method development; pharmacokinetic application; raloxifene hydrochloride; rat plasma; validation.
Subjects: R Medicine > RS Pharmacy and materia medica
Faculty/Division: Faculty of Engineering Technology
Depositing User: Dr. Syed Mahmood
Date Deposited: 05 Feb 2018 02:31
Last Modified: 05 Feb 2018 02:31
URI: http://umpir.ump.edu.my/id/eprint/19791
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