RP-HPLC法测定卡铂制剂中卡铂的含量

目的:建立卡铂制剂中卡铂含量的测定方法。方法:采用高效液相色谱法。色谱柱为SHIMADZURP-C18柱,流动相为含2卡.5铂m检m·测L浓-1度辛在基磺10酸.1～钠5的05水.0溶μg·液m-甲L-醇1范(9围0内∶1与0)峰,流面速积为积1分.0值m线L·性mi关n-系1,良进好样(量r=为01.909μ9L9,)检;注测射波用长卡为铂22及9卡nm铂,注柱射温液为的40低℃、。中结、高果平:均回收率分别为98.36%、98.90%、97.96%和98.15%、97.77%、98.43%,RSD分别为0.63%、0.83%、0.42%、0.44%、0.72%、0.45%(n=9)。结论:该法具有样品处理简单、稳定性高、简便快捷、准确度高等特点,具有较好的实用性。

Content Determination of Carboplatin in Carboplatin Preparation by RP-HPLC

OBJECTIVE： To establish the method for the content determination of carboplatin in Carboplatin preparation. METHODS： HPLC method was adopted. The determination was performed on a SHIMADZU RP-C18 colum with a mobile phase consisted of 2.5 mm.L^-1 octyl-sodium sulfonate-methanol （90： 10） at a flow rate of 1.0 mL.min^-1. The injection volume was 10μL and the UV detection wavelength was set at 229 nm. The column temperature was 40℃. RESULTS ： The linear range of carboplatin was 10.1-505.0 μg. mL^-1 （r=0.999 9）. Average recoveries of it of carboplatin for injection and carboplatin injection were 98.36%, 98.90%, 97.96% and 98.15%, 97.77%, 98.43% （n=9）, with RSD of 0.63%, 0.83%, 0.42% and 0.44%, 0.72%, 0.45%. CONCLUSION： The method is simple, stable, convenient, accurate and rapid, and it is practical.