Polarographic determination of temazepam in soft gelatin capsule formulations

Abstract

Precise and accurate procedures have been developed for the polarographic determination of temazepam in soft gelatin capsules. The capsule contents can be determined either by direct-current or by differential-pulse polarography. In order to cover the possibility of temazepam having diffused into the capsule shell a whole capsule assay has been developed based on directcurrent polarography: the differential pulse signal is considerably suppressed by the gelatin present in the shell. For capsules that have undergone storage tests at high temperatures leading to denaturisation, an enzyme dissolution step is included. The procedures are not subject to interference from known degradation products, and can therefore be used for stability determinations.