A Stability Indicating RP-HPLC Method for the Estimation of Gemcitabine HCl in Injectable Dosage forms
A Stability Indicating RP-HPLC Method for the Estimation of Gemcitabine HCl in Injectable Dosage forms
复制标题
用于测定注射剂型中盐酸吉西他滨浓度的稳定性指示 RP-HPLC 方法
DOI：
10.1155/2010/724915
复制
发表时间：
2010
影响因子：
--
通讯作者：
J. Rao
中科院分区：
文献类型：
--
作者：
S. Mastanamma;G. Ramkumar;D. A. Kumar;J. Rao
建立了测定盐酸吉西他滨含量的反相高效液相色谱法。色谱柱为ODS C18柱（250×4.6 mm; 5μ m），移动的相为甲醇-磷酸盐缓冲液（40：60 v/v），流速为1.0 mL/min，检测波长为270 nm。发现药物的保留时间为2.31 min。该方法在10 - 60 μg/mL盐酸吉西他滨浓度范围内产生线性响应。发现该方法对于分析注射剂型中的药物具有重现性。通过强制降解研究评估药物的稳定性。
A stability indicating RP HPLC method has been developed for the determination of gemcitabine hydrochloride. Chromatography was carried out on an ODS C18 column (250×4.6 mm; 5μ) using a mixture of methanol and phosphate buffer (40: 60 v/v ) as the mobile phase at a flow rate of 1.0 mL/min. The detection of the drug was monitored at 270 nm. The retention time of the drug was found to be 2.31 min. The method produced linear responses in the concentration range of 10 to 60 μg/mL of gemcitabine HCl. The method was found to be reproducible for analysis of the drug in injectable dosage forms. The stability of the drug was assessed by forced degradation studies.