Preparation and Quality Control of Thermo-sensitive Paclitaxel Liposomes
10.3870/yydb.2014.11.024
- VernacularTitle:紫杉醇热敏脂质体的制备与质量控制
- Author:
Zhiping LI
;
Xiqing ZHAO
;
Shiqing ZHAO
;
Hui ZHANG
;
Yan LIU
;
Ruolei XIAO
- Publication Type:Journal Article
- Keywords:
Thermo-sensitive liposomes with paclitaxel;
Haemolysis;
HPLC;
Quantity control
- From:
Herald of Medicine
2014;(11):1486-1490
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare long-circulating temperature-sensitive liposomes with paclitaxel( LTSLP ),develop methods for determination of paclitaxel,related substances and monostearoyl phosphatidylcholine( MSPC ) in LTSLP,and the haemolysis of LTSLP in vitro. Methods HPLC-UV methods for paclitaxel content and related substances and HPLC-CAD method for MSPC in LTSLP were established and validated. Spectrophotometric method was used to determine hemolysis in vitro. Results There was a good linear relationship between peak area and concentration within the range of 60. 39-181. 17μg·mL-1 . Recovery and precision of the method for determination of paclitaxel content met the requirements. Specificity,sensitivity,and system suitability for related substances were consistent with requirements. There was a good linear relationship between peak area and concentration within the range of 1. 5-50. 0μg·mL-1 for the determination of MSPC with good specificity,sensitivity and recovery. Paclitaxel contents in three batches of self-prepared LTSLP were between 90. 0% and 110. 0%,single related substances were below 0. 5% and total impurities were below 2. 0%. There was almost no hemolysis in vitro. Conclusion The methods for determining paclitaxel content,related substances and haemolysis can be used to assess the quality of LTSLP. Self-produced LTSLP consistently meet the quality standards.
