The purpose of stability testing is to provide insight into the stability of a drug substance or drug product over time, and under the influence of environmental factors (e.g., temperature, humidity, and light) and in vivo factors (e.g., pH and liver microsomes).
Evaluating the stability of drug substances and products is significant to determining drug quality, as it contributes to the efficacy of any drug or its dosage form. Regular testing is considered to be the only way to ensure delivery of the right therapeutic values to patients during treatment.
Instability due to the pH of the stomach (pH 2.0) or the intestine (pH 8.0) can significantly affect bioavailability. Compounds may also be exposed to degradation by in vitro bioassay test matrices that vary in pH. The resulting degradation can confuse structure-activity relationship (SAR) results, leading to dead ends and loss of valuable time for a drug discovery project.
It is therefore necessary to study the effect of a variety of pH levels on the stability of drug candidates.
Given the detection speed and sensitivity of UPLC/MS/MS, the Waters ACQUITY TQD System used in conjunction with specialized software, ProfileLynx and QuanOptimize Application Managers, is the ideal choice for analysis of drug degradation resulting from pH.
Using ProfileLynx and QuanOptimize Application Managers allowed for: