GC Method for Determination of Piperidine Compounds and its Application to the Industrial Process Control of Active Pharmaceutical Ingredients

Abstract

Objective: For the purpose of industrial process control (IPC) of active pharmaceutical ingredients (APIs), a convenient and rapid analytical method was indispensable.

Method: in this study, a simple, precise method for the determination of two piperidine-type drug intermediates using gas chromatography coupled with a nitrogen phosphorus detector (GC–NPD) was developed and validated. The linearity, precision, accuracy and recovery of the method were validated to demonstrate that the method was specific and precise.

Result: the LODs and LOQs of substituted piperidine (SP) and substituted 1-butyl-piperidine (SBP) were 1.0 and 2.0, 1.0 and 2.5ng/mL, respectively. The method was then applied to the determination of IPC samples for monitoring the progress of the reaction and optimizing the conditions.

Conclusion: the method could also be applied to the determination for other heterocycle compounds.