1.1 本试验方法用于通过高效液相色谱法（HPLC）分离脂质体制剂中的脂质，并使用质量流量敏感带电气溶胶检测器（CAD）对其进行定量。 1.2 本试验方法专门用于含有胆固醇、1,2-二硬脂酰-sn-甘油-3-磷酸乙醇胺-N-[甲氧基（聚乙二醇）-2000]（DSPE-PEG 2000）和氢化大豆L-α-磷脂酰胆碱（HSPC）的脂质体制剂。 1.3 本试验方法适用于报告胆固醇、DSPE的绝对浓度和比率- 脂质体制剂中的PEG 2000和HSPC。根据氧化或水解导致的降解曲线评估分析物的稳定性超出了本试验方法的范围。 1.4 该测试方法包括校准标准制备、样品制备、方法验证和样品分析。该方法还包含仪器和色谱实验程序的规范。 1.5 本试验方法中分析物的检测限和定量限在0范围内。 分别为1-2.0μg/g和1.0-5.0μg/g。胆固醇、DSPE-PEG 2000和HSPC的分析测量范围为5–300µg/g。 1.6 所有观察值和计算值应符合实践中确定的有效数字和舍入准则 D6026 . 1.7 单位- 以国际单位制表示的数值应视为标准。在适当情况下，本标准包括国际单位制以外的通用单位制。 1.8 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 制药行业对脂质体制剂的兴趣与日俱增，这就要求对形成脂质体的脂质进行质量控制和全面的定性和定量 ( 6. ) . 脂质成分已被证明是脂质体制剂的关键属性；它直接影响制剂的稳定性、载药量、脂质体的性能、大小和表面特性。胆固醇通过增加脂质体的稳定性在药物控释中发挥关键作用 ( 7. ) . 脂质成分和成分比例的显著变化将影响脂质体制剂的安全性、生物分布、药物疗效和药物释放动力学 ( 8- 11 ) . 5.2 本试验方法是一种快速可靠的程序，用于使用HPLC-CAD定量脂质体制剂中的胆固醇、DSPE-PEG 2000和热休克蛋白C。 5.3 该试验方法可用于QC和QA，并确定脂质体制剂成分分析中的变化。

1.1 This test method is for the separation of lipids in liposomal formulations through high performance liquid chromatography (HPLC) and their quantitation using a mass-flow sensitive charged aerosol detector (CAD). 1.2 This test method is specifically for liposomal formulations containing cholesterol, 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethylene glycol)-2000] (DSPE-PEG 2000) and hydrogenated soy L-α-phosphatidylcholine (HSPC). 1.3 This test method is applicable to report the absolute concentrations and ratio of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations. Assessment of the stability of the analytes in terms of their degradation profiles as a result of oxidation or hydrolysis is beyond the scope of this test method. 1.4 This test method includes calibration standards preparation, sample preparation, method validation, and sample analysis. This method also contains specifications for instrumentation and the chromatography experimental procedure. 1.5 The detection limit and quantitation limit for the analytes in this test method is in the range of 0.1–2.0 µg/g and 1.0–5.0 μg/g respectively. The analytical measurement range for cholesterol, DSPE-PEG 2000, and HSPC is 5–300 µg/g. 1.6 All observed and calculated values shall conform to the guidelines for significant digits and rounding as established in Practice D6026 . 1.7 Units— The values stated in SI units are to be regarded as the standard. Where appropriate, c.g.s units in addition to SI units are included in this standard. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 The growing interest in liposomal formulations in the pharmaceutical industry requires QC and thorough characterization and quantification of lipids that form liposomes ( 6 ) . Lipid composition has proven to be a critical attribute of the liposomal formulation; it directly influences the stability of the formulation, drug loading, performance, size, and surface characteristics of the liposome. Cholesterol plays a key role in controlled drug release by adding stability to the liposome ( 7 ) . Significant variation in the lipid composition and ratio of the components will influence the safety, biodistribution, drug efficacy, and drug release kinetics of the liposomal formulation ( 8- 11 ) . 5.2 This test method is a fast and reliable procedure for the quantification of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations using HPLC-CAD. 5.3 This test method can be used for QC and QA and to ascertain variations in component profiling of liposomal formulations.