Gupta Vishnu D
Pharmaceutics Division, University of Houston, Houston, Texas.
Int J Pharm Compd. 2008 Jul-Aug;12(4):372-4.
The chemical stability of perphenazine in two commercially available vehicles for oral liquid dosage forms was studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in our laboratory. The results indicate that the recommended beyond-use date of 180 days in Ora-Sweet syrup vehicle (final pH of the dosage form was 4.2) is not valid for this product. However, in Humco's simple syrup (final pH of the dosage form was 4.5), perphenazine was stable for at least 183 days. The decomposition of perphenazine followed first order law. The decomposition constant at room temperature in Ora-Sweet syrup vehicle was 2.3 times higher (0.0007 per day) versus in Hucmco's simple syrup (0.0003 per day). The pH values of both dosage forms remained constant, and the physical appearance of both dosage forms did not change during this study period. For a stable oral liquid dosage form did not change during this study period. For a stable oral liquid dosage form of perphenazine, the pH value is very critical.
采用我们实验室开发的一种稳定性指示高效液相色谱分析方法，研究了奋乃静在两种市售口服液体剂型载体中的化学稳定性。结果表明，在Ora - Sweet糖浆载体中建议的180天有效期（剂型最终pH值为4.2）对该产品无效。然而，在Humco的单糖浆中（剂型最终pH值为4.5），奋乃静至少稳定183天。奋乃静的分解遵循一级定律。在室温下，Ora - Sweet糖浆载体中的分解常数（每天0.0007）比Humco单糖浆中的（每天0.0003）高2.3倍。在本研究期间，两种剂型的pH值保持恒定，且两种剂型的外观均未改变。对于稳定的口服液体剂型，在本研究期间未发生变化。对于稳定的奋乃静口服液体剂型，pH值非常关键。
