Identification and quantification of five impurities in cloperastine hydrochloride.

Cloperastine hydrochloride, a piperidine derivative, is a drug substance with a central antitussive effect and widely used in cough treatment; and its impurities have not been reported. Herein we isolated and identified five impurities (named as impurity A, B, C, D and E) in cloperastine hydrochloride bulk drug and developed a quantitative HPLC method. First, impurity A, B, C were enriched by ODS column chromatography and isolated by semi-preparative HPLC, at the same time, impurity D was purified by ODS column chromatography.

[Pharmacokinetics of S-1 capsule in patients with advanced gastric cancer].

The study is to investigate the pharmacokinetics of S-1 capsule (tegafur, gimeracil and potassium oxonate capsule) in patients with advanced gastric cancer after single and multiple oral administration. Twelve patients with advanced gastric cancer were recruited to the study. The dose of S-1 for each patient was determined according to his/her body surface area (BSA).

Comparison of three derivatization reagents for the simultaneous determination of highly hydrophilic pyrimidine antitumor agents in human plasma by LC-MS/MS.

A comparison of three derivatization reagents (dansyl chloride, diazomethane and p-bromophenacyl bromide) for the simultaneous quantitation of three anticancer chemicals (tegafur, 5-fluorouracil and gimeracil) and endogenous uracil in plasma using high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been developed and evaluated. Through a comprehensive consideration, p-bromophenacyl bromide (p-BPB) was finally selected as the derivatization reagent. Because it essentially changed the chromatographic behavior of the aforementioned highly hydrophilic compounds and significantly enhanced their sensitivities.