Kirk Loren Madden, Brown Stacy D
Bill Gatton College of Pharmacy at East Tennessee State University, Department of Pharmaceutical Sciences, Johnson City, TN, USA.
Bill Gatton College of Pharmacy at East Tennessee State University, Department of Pharmaceutical Sciences, Johnson City, TN, USA
J Feline Med Surg. 2015 Dec;17(12):1035-40. doi: 10.1177/1098612X15569329. Epub 2015 Feb 13.
The objectives of this study included developing and validating a stability-indicating high-performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection for the determination of buprenorphine in a buccal solution for veterinary use, and applying that method to determine the stability of a 3 mg/ml buprenorphine preparation in room temperature and refrigerated storage conditions. This preparation, intended for buccal administration in feline patients, plays an important role in pain management in cats.
A stability-indicating HPLC method was developed and validated for system suitability, accuracy, repeatability, intermediate precision, specificity, linearity and robustness based on US Pharmacopeia (USP) General Chapter <1225>. The method was then applied to the study of potency changes over 90 days in a buccal buprenorphine solution stored at two temperatures.
All HPLC-UV method data met acceptable criteria for the quantification of buprenorphine in a buccal solution formulation. The buprenorphine concentrations found in each stability sample remained within the 90-110% of label claim throughout the 90 days of study. All stability test bottles of the buprenorphine buccal solution retained their original appearance. For the room temperature bottles, some white particulate matter was noted in the threads of the container bottles starting at day 21. The pH of the preparations during the course of the study was in the range of 3.57-4.06 and 4.01-4.16 for the room temperature and refrigerated samples, respectively.
Pharmacists have compounded a concentrated 3 mg/ml buccal solution to use easily in the home care or outpatient setting for treatment of feline pain. Prior to this investigation, pharmacists empirically assigned beyond-use dates to this formulation based on standards in USP General Chapter <795> Pharmaceutical Compounding - Nonsterile Preparations. This study of a 3 mg/ml buprenorphine buccal solution indicates stability through 90 days.
本研究的目的包括开发并验证一种采用紫外（UV）检测的稳定性指示高效液相色谱（HPLC）法，用于测定兽用口腔溶液中的丁丙诺啡，并应用该方法测定3mg/ml丁丙诺啡制剂在室温及冷藏储存条件下的稳定性。这种制剂用于猫科动物患者的口腔给药，在猫的疼痛管理中发挥着重要作用。
根据美国药典（USP）通则<1225>，开发并验证了一种稳定性指示HPLC法，用于系统适用性、准确性、重复性、中间精密度、特异性、线性和稳健性。然后将该方法应用于研究在两种温度下储存的丁丙诺啡口腔溶液90天内的效价变化。
所有HPLC-UV法数据均符合口腔溶液制剂中丁丙诺啡定量的可接受标准。在整个90天的研究中，每个稳定性样品中测得的丁丙诺啡浓度保持在标签标示量的90%-110%范围内。所有丁丙诺啡口腔溶液的稳定性测试瓶外观保持原样。对于室温瓶，从第21天开始，在容器瓶的螺纹处发现了一些白色颗粒物。在研究过程中，室温样品和冷藏样品制剂的pH值分别在3.57-4.06和4.01-4.16范围内。
药剂师配制了一种浓度为3mg/ml的浓缩口腔溶液，便于在家护或门诊环境中用于治疗猫科动物疼痛。在本次研究之前，药剂师根据USP通则<795>《药物配制 - 非无菌制剂》中的标准，凭经验为该制剂指定了有效期。这项对3mg/ml丁丙诺啡口腔溶液的研究表明其在90天内具有稳定性。
