使用OPTIC-IMS热解吸-离子迁移谱系统对药物氯吡格雷进行清洁验证

来源: 图拉扬科技发布日期: 2022-10-10 访问量: 502

导读	清洁验证是药物生产过程中至关重要的一步。它是为了确保在一件设备中不同产品之间切换时不会发生交叉污染。标准的清洁验证程序是基于使用液相色谱(LC)检查清洁度。平均而言，假设验证测试已经通过，在生产过程恢复到下一次运行之前，它需要大约需要30分钟和大量的有机溶剂标签: OPTIC、IMS离子迁移谱、AIMS、Clopidogrel氯吡格雷

Keywords关键词: OPTIC, IMS, AIMS, Clopidogrel

Introduction介绍

Cleaning validation is a vital step in the drug production process. It is to ensure that no cross-contamination occurs while switching between different products in a piece of equipment. Standard cleaning validation procedures are based on checking the cleanliness using liquid chromatography (LC). In average, it takes approx. 30 minutes and a significant amount of organic solvent before the production process is resumed into a next run assuming that the validation test has passed.

清洁验证是药物生产过程中至关重要的一步。它是为了确保在同一设备中不同产品之间切换时不会发生交叉污染。标准的清洁验证程序是基于使用液相色谱(LC)检查清洁度。平均而言，假设验证测试已经通过，在生产过程恢复到下一次运行之前，它需要大约需要30分钟和大量的有机溶剂。

In this study it is shown that the cleaning cycle can be significantly reduced when using a fast IMS measurement technique. The cleaning examination is performed using Clopidogrel as a sample drug.

在这项研究中，当使用IMS快速测量技术时，清洗周期可以显著减少。清洁检查使用氯吡格雷作为样本药物进行

Analytical conditions实验条件:

Analyzer分析仪:	OPTIC-AIMS, GL Sciences. MaSaTech.
Transfer Line导管:	Fused Deactivated Silica, 0.25mm x 0.1 m
Temperature transfer line导管温度:	200°C
Injection mode进样模式:	OPTIC Expert mode
Sample volume样品体积:	1 µL sample
Inlet temperature program温度程序:	50°C 、60.0 °C/s、400°C Column Flow: 20.0 mL/min conditioned Air
Venting排气:	75 mL/min conditioned Air, 6 sec
Drift tube temperature飘移管温度:	180°C
Drift Flow漂移气体流量:	900 mL/min conditioned Air
Analysis Time分析时间:	150 s (including cool down time)

Sample Preparation样品制备:

The samples were taken from a reaction chamber that was used to produce Clopidogrel. A swab sample was prepared by wiping the chamber horizontally on one side of the swab. Each swab sample was then placed into a 20 mL vial containing 10 mL of Methanol. The vial was shaken for 2 minutes afterwards. 1 µL of the extract was injected into the OPTIC-AIMS.

这些样品是从用于生产氯吡格雷的反应室中提取。通过在拭子的一侧水平擦拭反应室，制备拭子样本。然后将每个拭子样本放入一个包含10 mL甲醇的20 mL小瓶中。然后摇小瓶2分钟。取1µL的提取液注入OPTIC-AIMS系统

Peak discovery峰特征:

Step 1: 1 µL injection of 0,7 µg/mL Clopidogrel in Methanol into the OPTIC-AIMS.

步骤1: 注入0.7µg/mL甲醇氯吡格雷1µL至OPTIC-AIMS中

Conclusions结论:

As it is seen from the 2D plasmagrams, the OPTIC-AIMS analyzer is very much capable of detecting low concentrations of Clopidogrel. The compound is clearly visible before the wet cleaning. After the wet cleaning, the Clopidogrel is not detected. In accordance with the existing regulation, it is not permitted to have more than 0.7 ng/µL of Clopidogrel which is equivalent to 7 µg/swab rinsed with 10 mL of solvent.

从离子迁移2D图谱可以看出，OPTIC-AIMS分析仪非常有能力检测低浓度的氯吡格雷。该化合物在湿式清洗前清晰可见。在湿洗后，氯吡格雷未被检测到。按照现行规定，不允许有超过0.7 ng/µL的氯吡格雷，相当于7µg/拭子，用10 mL溶剂漂洗。

The OPTIC-AIMS system runs on conditioned (dry and cleaned) air. The analysis time is within 3 minutes. A low amounts of solvent (Methanol) is used for the sample preparation. At the same time, if an LC system is used for the cleaning validation, it consumes about 500 liter of solvent per year for the mobile phase if flow of 1 mL/min is maintained.

OPTIC-AIMS系统在经过调节(干燥和清洁)的空气中运行。分析时间在3分钟内。样品制备使用少量的溶剂(甲醇)。同时，如果使用LC系统进行清洗验证，如果保持1 mL/min的流量，每年流动相需要消耗约500升溶剂。

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