Nirogi Ramakrishna, Kota Srinivasulu, Katta Raja Rajeswari, Vennila Saritha, Kandikere Vishwottam, Mudigonda Koteshwara, Vurimindi Hima Bindu
Suven Life Sciences Limited, Serene Chambers, Road # 5, Avenue 7, Banjara Hills, Hyderabad - 500034, India.
J Chromatogr Sci. 2008 Oct;46(9):764-6. doi: 10.1093/chromsci/46.9.764.
A chiral liquid chromatographic method is developed for the enantiomeric resolution of Linezolid, (S)(-)-N-[[-3-(3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl] acetamide, an antibiotic in bulk drugs. The enantiomers of Linezolid are resolved on a Chiralcel OJ-RH column using a mobile phase system containing 150mM di-sodium hydrogen phosphate buffer (pH 4.5)-acetonitrile (86:14, v/v). The resolution between the enantiomers is found to be two. The developed method is extensively validated and proved to be robust. The limit of detection and limit of quantification of (R)-enantiomers are found to be 94 and 375 ng/mL, respectively, for 10 microL injection volume. The percentage recovery of (R)-enantiomer is ranged from 98.9 to 102.9 in bulk drug samples of Linezolid. Linezolid sample solution and mobile phase are found to be stable for at least 48 h. The proposed method is found to be suitable and accurate for the quantitative determination of (R)-enantiomer in bulk drugs.
开发了一种手性液相色谱法，用于对利奈唑胺（(S)(-)-N-[[3-(3-氟-4-(4-吗啉基)phenyl]-2-氧代-5-恶唑烷基]甲基]乙酰胺）进行对映体拆分，利奈唑胺是一种原料药中的抗生素。利奈唑胺的对映体在Chiralcel OJ-RH柱上进行拆分，使用含有150mM磷酸氢二钠缓冲液（pH 4.5）-乙腈（86:14，v/v）的流动相系统。对映体之间的分离度为2。所开发的方法经过了广泛验证，证明是稳健的。对于10微升进样体积，(R)-对映体的检测限和定量限分别为94和375 ng/mL。在利奈唑胺的原料药样品中，(R)-对映体的回收率在98.9%至102.9%之间。利奈唑胺样品溶液和流动相至少在48小时内稳定。所提出的方法被认为适用于并准确测定原料药中(R)-对映体的含量。
