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

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 phas...

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Bibliographic Details
Main Authors: Syed Jaffri, Syed Mahmood, Sengupta, Pinaki Ranjan, Mandal, Uttam Kumar, Chatterjee, Bappaditya D., Bakhtiar, M. Taher
Format: Article
Language:English
English
Published: Colegio de Farmaceuticos de la Provincia de Buenos Aires 2017
Subjects:
Online Access:http://irep.iium.edu.my/58589/
http://irep.iium.edu.my/58589/
http://irep.iium.edu.my/58589/1/Latin%20Journal%20LAJOP_36_9_1_35.pdf
http://irep.iium.edu.my/58589/7/58589_Development%2C%20validation_scopus.pdf
Description
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.