title: Chiral Separation of Ormeloxifene Hydrochloride, a Non-steroidal Contraceptive Agent.
abstract: Ormeloxifene hydrochloride (Centchroman) is once-a-week non-steroidal oral contraceptive agent marketed in India and other countries. In this study, we report a validated isocratic high-performance liquid chromatographic (HPLC) method for chiral separation of D- and L-ormeloxifene hydrochloride. This method is capable of baseline separation of its D- and L-isomers. HPLC separation was achieved on a Lux 5µ cellulose-1 with a mobile phase comprising hexane, isopropanol, methanol and triethylamine (90:10:1:0.5). Validation parameters such as limit of detection, limit of quantitation, linearity, precision, accuracy, specificity and preformulation studies were conducted according to new guidelines of International Conference on Harmonization.
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, BS 10/1, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226021, India.
authors.forename: Hafsa
authors.initials: H
authors.lastname: Ahmad
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, BS 10/1, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226021, India.
authors.forename: Varsha
authors.initials: V
authors.lastname: Gupta
authors.affiliation: Division of Medicinal and Process Chemistry, Central Drug Research Institute, BS 10/1, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226021, India.
authors.forename: Atma Prakash
authors.initials: AP
authors.lastname: Dwivedi
authors.affiliation: Division of Medicinal and Process Chemistry, Central Drug Research Institute, BS 10/1, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226021, India.
authors.forename: S B
authors.initials: SB
authors.lastname: Katti
authors.affiliation: Division of Pharmaceutics, Central Drug Research Institute, BS 10/1, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226021, India anilcdri@gmail.com.
authors.forename: Anil Kumar
authors.initials: AK
authors.lastname: Dwivedi
mesh_terms: D001578:Benzopyrans / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003270:Contraceptive Agents / Q000737:chemistry*; D057230:Limit of Detection; D013237:Stereoisomerism
chemical_list: D001578:Benzopyrans; D003270:Contraceptive Agents; C508548:ormeloxifene