Boca Madalina Brindusa, Apostolides Zeno, Pretorius Etheresia
Department of Anatomy, Faculty of Medicine, University of Pretoria, 0002 Pretoria, South Africa.
J Pharm Biomed Anal. 2005 Mar 9;37(3):461-8. doi: 10.1016/j.jpba.2004.10.045. Epub 2004 Dec 15.
Analytical method validation, determining the recovery rate from the equipment surface and the stability of a potential contaminant are important steps of a cleaning validation process. A rapid, sensitive and reproducible reversed-phase high-performance liquid chromatographic method was developed for the determination of pyrimethamine (PYR) and sulfadoxine (SUL) in cleaning validation swab samples. The active compounds can be selectively quantified in a sample matrix containing detergent and swab material as low as 0.12 microg/ml. The swabbing procedure used on stainless steel coupons was validated and the stability of PYR and SUL in the swab samples was assessed. The calculated limit of contamination values for PYR (4.99 microg/cm2) and SUL (19.14 microg/cm2) were not exceeded during four consecutive equipment cleaning trials. This confirms that the desired level of cleanliness is achieved with the current cleaning procedures, which are consequently validated.
分析方法验证、确定设备表面的回收率以及潜在污染物的稳定性是清洁验证过程的重要步骤。开发了一种快速、灵敏且可重现的反相高效液相色谱法，用于测定清洁验证擦拭样本中的乙胺嘧啶（PYR）和磺胺多辛（SUL）。在含有低至0.12微克/毫升洗涤剂和擦拭材料的样本基质中，可以选择性地对活性化合物进行定量。对不锈钢试片上使用的擦拭程序进行了验证，并评估了PYR和SUL在擦拭样本中的稳定性。在连续四次设备清洁试验中，PYR（4.99微克/平方厘米）和SUL（19.14微克/平方厘米）的计算污染限值均未超过。这证实了当前的清洁程序达到了所需的清洁水平，因此该程序通过了验证。
