Development, validation and pharmacokinetic application of a simple and robust RP-HPLC method for quantitation of raloxifene in rat plasma

Syed Jaffri, Syed Mahmood and Sengupta, Pinaki Ranjan and Mandal, Uttam Kumar and Chatterjee, Bappaditya D. and Bakhtiar, M. Taher (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. 1901-1907. ISSN 0326 2383

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Abstract

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 (Journal)
Additional Information:	7745/58589
Uncontrolled Keywords:	Bioanalytical method development; Pharmacokinetic application; Raloxifene hydrochloride; Rat plasma; Validation
Subjects:	R Medicine > RM Therapeutics. Pharmacology > RM300 Drugs and their action
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Pharmacy > Department of Pharmaceutical Technology
Depositing User:	Dr Muhammad Taher
Date Deposited:	02 Oct 2017 12:42
Last Modified:	18 Apr 2018 11:19
URI:	http://irep.iium.edu.my/id/eprint/58589

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