Development, Validation and Pharmacokinetic Application of a Simple and Robust RP-HPLC Method for Quantitation of Raloxifene in Rat Plasma
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...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
College of Pharmacists of Buenos Aires Province, Argentina
2017
|
| Subjects: | |
| Online Access: | http://umpir.ump.edu.my/id/eprint/19791/ http://umpir.ump.edu.my/id/eprint/19791/ http://umpir.ump.edu.my/id/eprint/19791/ http://umpir.ump.edu.my/id/eprint/19791/1/ftech-2017-mahmood-Development%2C%20Validation%20and%20Pharmacokinetic%20Application1.pdf |
| Summary: | 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. |
|---|