Display Settings:

Format

Send to:

Choose Destination

    Pharmacol Res. 2005 Oct;52(4):334-9.

    HPLC analysis of raloxifene hydrochloride and its application to drug quality control studies.

    Trontelj J, Vovk T, Bogataj M, Mrhar A.

    Faculty of Pharmacy, University of Ljubljana, Askerceva 7, 1000 Ljubljana SI-1000, Slovenia. jurij.trontelj@ffa.uni-lj.si

    Raloxifene hydrochloride is a selective estrogen receptor modulator and is currently being used for prevention of osteoporosis in postmenopausal women. In this article, a high performance liquid chromatography (HPLC) method for detection of raloxifene hydrochloride was developed and validated using an ultraviolet (UV) and coulometric detectors. Limit of quantification (LOQ) was 0.336 and 0.610 mg L(-1) for coulometric and ultraviolet detectors, respectively. Acceptable accuracy (93.1-100.3%) as well as intra- and inter-day precision (CV<or=2.38% and CV<or=7.93%, respectively) was demonstrated in the range of 0.5-10 mg L(-1) for both detectors. The presented method was applied without any interference of excipients to the determination of raloxifene hydrochloride content in tablets and to the in vitro dissolution studies. The proposed method could be used for routine quality control. Moreover, due to its low LOQ, excellent accuracy, precision and selectivity, the coulometric detection could be applied to in vitro metabolism experiments such as microsome or hepatocyte preparations and for studies of transport of raloxifene hydrochloride across biological membranes.

    PMID: 15979892 [PubMed - indexed for MEDLINE]

    Supplemental Content

    Click here to read

    Patient drug information

    • Estrogen (Cenestin®, Enjuvia®, Estrace®, ...)

      Estrogen is used to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause ('change of life', the end of monthly menstrual periods). Some brands of estrogen...

    • Tamoxifen (Nolvadex®)

      Your doctor has prescribed tamoxifen for you. Tamoxifen comes as a tablet to take by mouth.

    • Raloxifene (Evista®)

      Raloxifene is used to prevent and treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause (change of life; end of menstrual periods). Raloxifene is al...