Rao Kareti Srinivasa, Kumar Keshar Nargesh, Joydeep Datta
Roland Institute of Pharmaceutical Sciences, Berhampur, Orissa-760 010, India.
Sci Pharm. 2011 Oct-Dec;79(4):899-907. doi: 10.3797/scipharm.1104-25. Epub 2011 Aug 7.
A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS was 2.733 min and its formulation was exposed to acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 0.5-200μg/ml. The percentage recovery was 99.46. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than the critical value.
开发了一种简单的稳定性指示反相高效液相色谱法，并随后对其进行验证，以测定药物剂型中存在的硫酸头孢匹罗（CPS）。所提出的反相高效液相色谱法采用LiChroCART-Lichrosphere100、C18反相柱（250 mm×4mm×5μm），在等度分离模式下，流动相由甲醇和水按50:50%（v/v）的比例组成，流速为1ml/min，流出物在270nm处进行监测。CPS的保留时间为2.733分钟，其制剂暴露于酸性、碱性、光解、热和氧化应激条件下，并用所提出的方法对应激样品进行分析。所述方法在0.5-200μg/ml范围内呈线性。回收率为99.46%。使用95%置信水平的F检验和t检验来检查在不同实验设置下获得的中间精密度数据；发现计算值小于临界值。
