title: Beyond-use date determination of buprenorphine buccal solution using a stability-indicating high-performance liquid chromatographic assay.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Bill Gatton College of Pharmacy at East Tennessee State University, Department of Pharmaceutical Sciences, Johnson City, TN, USA.
authors: Loren Madden
authors: LM
authors: Kirk
authors: Bill Gatton College of Pharmacy at East Tennessee State University, Department of Pharmaceutical Sciences, Johnson City, TN, USA brownsd03@etsu.edu.
authors: Stacy D
authors: SD
authors: Brown
mesh_terms: D000278:Administration, Buccal; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000737:chemistry*; D000818:Animals; D002047:Buprenorphine / Q000008:administration & dosage / Q000737:chemistry*; D002415:Cats; D002851:Chromatography, High Pressure Liquid / Q000662:veterinary*; D004355:Drug Stability; D019999:Pharmaceutical Solutions; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000701:Analgesics, Opioid; D019999:Pharmaceutical Solutions; D002047:Buprenorphine