Davis Jennifer L, Kirk Loren Madden, Davidson Gigi S, Papich Mark G
Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC 27606, USA.
J Am Vet Med Assoc. 2009 Feb 1;234(3):385-9. doi: 10.2460/javma.234.3.385.
To determine the effects of temperature and light over a 35-day period on stability of pergolide mesylate after compounding in an aqueous vehicle.
Evaluation study.
Pergolide was compounded into a formulation with a final target concentration of 1 mg/mL. Aliquots of the formulation were then stored at -20 degrees, 8 degrees, 25 degrees, or 37 degrees C without exposure to light or at 25 degrees C with exposure to light for 35 days. Samples were assayed in triplicate by means of high-pressure liquid chromatography immediately after compounding and after 1, 7, 14, 21, and 35 days of storage.
Mean+/-SD concentration of pergolide in the formulation immediately after compounding was 1.05+/-0.086 mg/mL. Samples exposed to light while stored at 25 degrees C had undergone excessive degradation by day 14, samples stored at 37 degrees C had undergone excessive degradation by day 21, and samples stored at 25 degrees C without exposure to light had undergone excessive degradation by day 35. The decrease in expected concentration corresponded with the appearance of degradation peaks in chromatograms and with a change in color of the formulation.
Results indicated that pergolide mesylate was unstable after compounding in an aqueous vehicle and that storage conditions had an effect on stability of the compounded formulation. Compounded pergolide formulations in aqueous vehicles should be stored in a dark container, protected from light, and refrigerated and should not be used >30 days after produced. Formulations that have undergone a color change should be considered unstable and discarded.
确定在35天的时间里，温度和光照对甲磺酸培高利特在水性载体中复配后的稳定性的影响。
评估研究。
将培高利特复配成最终目标浓度为1mg/mL的制剂。然后将该制剂的等分试样分别储存在-20℃、8℃、25℃或37℃下，不暴露于光照中，或者在25℃下暴露于光照中35天。在复配后以及储存1、7、14、21和35天后，通过高压液相色谱法对样品进行一式三份的测定。
复配后制剂中甲磺酸培高利特的平均浓度±标准差为1.05±0.086mg/mL。在25℃下储存且暴露于光照的样品在第14天出现过度降解，在37℃下储存的样品在第21天出现过度降解，在25℃下储存且不暴露于光照的样品在第35天出现过度降解。预期浓度的降低与色谱图中降解峰的出现以及制剂颜色的变化相对应。
结果表明，甲磺酸培高利特在水性载体中复配后不稳定，储存条件对复配制剂的稳定性有影响。水性载体中的复配培高利特制剂应储存在深色容器中，避光，并冷藏，生产后使用时间不应超过30天。发生颜色变化的制剂应视为不稳定并丢弃。
