[Improvement Method of Confirmation Test of the In-pharmacy Formulation as Topical Medicine No. 37-①].

Topical Medicine No. 37-① is one of the in-pharmacy formulation that specifies a confirmation test (referred hereafter as the conventional method) to identify its ingredient diphenhydramine (DH) by colorimetric test. However, the conventional method is environmentally unfriendly due to the large amount of sample and organic solvent used, and the extraction process is complicated. We therefore developed three methods in view of improving the currently confirmation testing process: a simplified version of the conventional method, a TLC method, and an LC/photodiode array detector (PDA) method. The LC/PDA method was also examined for the quantitation of DH in order to determine its content in the medicine when needed. The LC/PDA method also demonstrated sufficient linearity in the calibration curve and recovery rate. We also evaluated whether the three methods developed in this study could be applied to Topical Medicine No. 37-①, which is made of absorptive cream containing different parabens.