Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction

Mahmood, Syed and Bakhtiar, M. Taher and Mandal, Uttam Kumar (2016) Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction. In: 2nd International Conference On Industrial Pharmacy 2016 (ICIP 2016), 15-16 August 2016, Kuantan, Pahang, Malaysia. (Unpublished)

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Abstract

A new, simple and sensitive HPLC method was developed for the quantification of raloxifene in rat plasma. Samples were prepared by liquid- liquid extraction method together with diclofenac sodium as internal standard (IS) at 2 μg/ml concentration. Separation of raloxifene from the treated samples was performed in a thermo-fisher syncronis RP- C18 column (150mm x 4.6 mm, 5μm particle size) at room temperature with a mobile phase containing acetonitrile and phosphate buffer of pH 6.1 (34:66 v/v) at a flow rate of 1 min/ml and ultraviolet detection at 285 nm. The developed method was validated for specificity, linearity, precision, accuracy, stability, sensitivity and recovery. Good linearity was achieved in the range of 125 ng/ml to 10 μg/ml (R2 = 0.9994). Precision and accuracy were within the acceptable limit of ICH guideline. Raloxifene was stable in quality control (QC) samples subjected to three freeze thaw cycles. QC Samples were also stable for 12 hours at room temperature, 3 months stored in deep freeze at -200C, and 12 hours after their processing (extraction followed by reconstitution with the mobile phase). The Overall recovery of raloxifene from the plasma samples were found to be within a range of 75.18% to 88.95%. The developed method was sensitive enough (LOQ: 125 ng/ml) that can be used to determine the plasma concentration of raloxifene in a pharmacokinetic study involving rats.

Item Type:	Conference or Workshop Item (Poster)
Additional Information:	5209/51874
Subjects:	R Medicine > RS Pharmacy and materia medica
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:	09 Sep 2016 11:26
Last Modified:	26 Sep 2016 16:09
URI:	http://irep.iium.edu.my/id/eprint/51874

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