Segretario J, Cook S C, Umbles C L, Walker J T, Woodeshick R W, Rubino J T, Shea J A
DuPont Merck Pharmaceutical Company, Pharmaceutical R & D, Wilmington, Delaware, USA.
Pharm Dev Technol. 1998 Nov;3(4):471-6. doi: 10.3109/10837459809028628.
The objective of this work was the development and validation of procedures designed to clean glass and stainless steel surfaces after exposure to the experimental anticancer drug, bisnafide. The cleaning procedures, using 5% acetic acid water, Alconox, and water, were validated using a wipe test and an HPLC method developed to quantitate low levels of bisnafide. The procedure developed for cleaning stainless steel is more stringent than that for glass because of the apparent greater affinity of bisnafide for stainless steel. The HPLC method is shown to be linear and reproducible (RSD 4.4% or less), with a detection limit of 4 ng/ml. Recoveries of 95.1, 83.5, and 70.0% were obtained from the wipe pads, glass plates, and stainless steel plates, respectively, at levels of approximately 0.7-1.7 ng/cm2. The cleaning procedures are shown to clean glass and stainless steel plates to less than 0.19 and 0.33 ng bisnafide/cm2, respectively. These results further demonstrate the need to fully characterize the recovery of drugs from surfaces and swabs in order to properly validate cleaning procedures. In addition, they demonstrate the potential need to develop surface-specific cleaning procedures.
这项工作的目的是开发并验证在接触实验性抗癌药物比奈法德后清洁玻璃和不锈钢表面的程序。使用5%醋酸水溶液、爱尔康诺克斯清洁剂和水的清洁程序，通过擦拭试验以及为定量检测低水平比奈法德而开发的高效液相色谱法进行了验证。由于比奈法德对不锈钢表面的亲和力明显更强，所以开发的不锈钢清洁程序比玻璃清洁程序更为严格。高效液相色谱法显示具有线性且可重现（相对标准偏差为4.4%或更低），检测限为4纳克/毫升。在约0.7 - 1.7纳克/平方厘米的水平下，从擦拭垫、玻璃板和不锈钢板上分别获得了95.1%、83.5%和70.0%的回收率。清洁程序能够将玻璃板和不锈钢板上的比奈法德分别清洁至低于0.19和0.33纳克/平方厘米。这些结果进一步表明，为了正确验证清洁程序，需要全面表征药物从表面和拭子上的回收率。此外，它们还表明可能需要开发针对特定表面的清洁程序。
