摘要
目的:建立测定卡铂注射液含量的方法,并考察溶媒、温度和光照对卡铂含量结果的影响。方法:采用高效液相色谱法。色谱柱为KromasilC18,流动相为甲醇-水(5∶95),流速为1mL·min-1,检测波长为229nm。在上述色谱条件下分别测定卡铂注射液在不同溶媒中(5%葡萄糖注射液、0.9%氯化钠注射液)、在不同温度(37、42、60℃)及在自然光照射下(5%葡糖糖注射液、蒸馏水)不同时间(8h内)时的含量变化。结果:卡铂检测浓度线性范围为4.2～33.6μg·mL-1(r=0.9999),平均回收率为99.72%(n=9)。8h内卡铂在2种溶液中含量百分比RSD分别为0.56%和0.27%;卡铂在3种温度下含量百分比RSD分别为1.15%、0.98%和1.60%;在自然光照射下2种溶液中含量百分比RSD分别为1.52%和0.45%。结论:所建立的卡铂制剂含量测定方法操作简便,结果准确;卡铂制剂在各种临床使用条件下含量均相对较稳定。
OBJECTIVE： To develop a method for the content determination of Carboplatin injection and to investigate the effect of solvent, temperature and light on the content of carboplatin. METHODS： HPLC was adopted. The analysis was carried out on Kromasil C18 column with a mobile phase consisted of methanol-water （5 ∶ 95） at a flow rate of 1 mL·min-1. The determination wavelength was set at 229 nm. With the chromatographic conditions mentioned above, the content change of carboplatin in different solution （5% glucose solution, 0.9% sodium chloride solution） at 37 ℃, 42 ℃ or 60 ℃ exposed to natural light were determined. RESULTS： The linear range of carboplatin was 4.2～33.6 μg·mL-1 （r=0.999 9） with an average recovery of 99.72% （n=9）. The RSD were 0.56% and 0.27% of carboplatin in 5% glucose solution and 0.9% sodium chloride solution within 8 hours. At 37 ℃, 42 ℃ or 60 ℃, the content percentage RSD were 1.15%, 0.98% and 1.60% within 8 hours, respectively. In exposure to natural light for 8 hours carboplatin in 5% glucose solution and in distilled water solution, content percentage RSD were 1.52% and 0.45%. CONCLUSION： Established method is simple and accurate, and the content of carboplatin preparation is relatively stable.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第5期442-444,共3页
China Pharmacy
