Method Development and Validation of RP-HPLC Method for the Estimation of Ormeloxifene

Anusha Shivaraj, Shireesha Battula


A new simple, specific, accurate, precise RP-HPLC method has been developed for the estimation of Ormeloxifene. The chromatographic separation for Ormeloxifene was achieved with mobile phase containing methanol :ACN(70:30 v/v), agilent C18 column (4.6 x150 mm) 5 μ at room temperature and UV detection at 274nm.The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Ormeloxifene was found to be 2.497min. The method was validated according to ICH guideline for linearity, specificity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines.


development; validation; RP-HPLC; estimation; ormeloxifene;

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Annu M, Tandon, Goel I, Mati M, Singh, Mastan, Singh, et al (2009). The effect of ormeloxifene, a selective estrogen receptor modulator, on the biomarkers of the endometrial receptivity and the pinopode development and its relationship with the fertility and the infertility in Indian subjects. Fertility and Sterility. 91 (6):2298–307.

A. Suneetha et al (2014). Innovative Method Development And Validation of Stability Indicating RP-HPLC Method For Determination of Ormeloxifene Hcl In Bulk And Pharmaceutical Dosage Form. J Pharm Res.13(1):11-15.

Biswas Subhash Chandra, Saha Sudip Kumar, Bag Tara Shankar, Ghosh Rey Samir, et al (2004). Ormeloxifene a selective estrogen receptor

modulator for treatment of dysfunctional menorrhagia. J Obstet Gynecollnd. 54(1):56-59.

Dhananjay BS, Sunil Kumar Nanda (2013). The role of sevista in the management of dysfunctional uterine bleeding. J Clin Diagn Res. 7(1):132-134.

Guideline on validation of analytical procedure-methodology. International Conference on Harmonization, Geneva, Switzerland, 1996.

Paliwal J K, et al (1996). Tissue distribution and pharmacokinetics of centchroman. A new nonsteroidal postcoital contraceptive agent and its 7-desmethyl metabolite in female rats after a single oral dose. Drug Metab Dispos. 24:148-155.

Praveen Kumar M, et al (2011). Stability-indicating Reversed-Phase High Performance Liquid Chromatography Method Formulation. Int J Chem Tech Res. 3:314-320.

Sheelendra Pratap Singh, et al (2008). Development and validation of a rapid, sensitive Liquid chromatography-tandem mass spectrometry using electorspray ionization for quantitation of centrochroman in rat plasma its application to pre-clinical pharmacokinetic study. J Chromato B.876:1-7.



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