HPLC analysis of raloxifene hydrochloride and its application to drug quality control studies.
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.
Trontelj
Jurij
J
Faculty of Pharmacy, University of Ljubljana, Askerceva 7, 1000 Ljubljana SI-1000, Slovenia. jurij.trontelj@ffa.uni-lj.si
Vovk
Tomaz
T
Bogataj
Marija
M
Mrhar
Ales
A
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D004965:Estrogen Antagonists / Q000032:analysis / Q000737:chemistry; D011786:Quality Control; D020849:Raloxifene Hydrochloride / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D020845:Selective Estrogen Receptor Modulators / Q000032:analysis / Q000737:chemistry; D012995:Solubility; D013607:Tablets / Q000032:analysis
D004965:Estrogen Antagonists; D020845:Selective Estrogen Receptor Modulators; D013607:Tablets; D020849:Raloxifene Hydrochloride