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利托那韦及其强制降解产物的 LC-MS/MS 研究。

LC-MS/MS studies of ritonavir and its forced degradation products.

机构信息

Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad, India.

出版信息

J Pharm Biomed Anal. 2010 Dec 1;53(4):833-42. doi: 10.1016/j.jpba.2010.06.004. Epub 2010 Jun 16.

DOI:10.1016/j.jpba.2010.06.004
PMID:20619992
Abstract

Forced degradation of ritonavir (RTV), under the conditions of hydrolysis (acidic, basic and neutral), oxidation, photolysis and thermal stress as prescribed by ICH was studied using LC-MS/MS. Eight degradation products were formed and their separation was accomplished on Waters XTerra C(18) column (250 mm x 4.6 mm i.d., 5 microm) using water:methanol:acetonitrile as (40:20:40, v/v/v) mobile phase in an isocratic elution mode by LC. The method was extended to LC-MS/MS for characterization of the degradation products and the pathways of decomposition were proposed. No previous reports were found in the literature regarding the characterization of degradation products of ritonavir.

摘要

采用 LC-MS/MS 法对利托那韦(RTV)在 ICH 规定的水解(酸、碱和中性)、氧化、光解和热应力条件下的强制降解进行了研究。生成了 8 种降解产物,并在 Waters XTerra C18 柱(250mm×4.6mmID,5μm)上用等度洗脱模式,以水:甲醇:乙腈为(40:20:40,v/v/v)流动相完成了它们的分离。该方法已扩展到 LC-MS/MS 用于降解产物的特征描述,并提出了分解途径。在文献中没有发现关于利托那韦降解产物特征描述的先前报道。

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