Method development, validation, identification and quantification of residual solvents in phenazopyridine hydrochloride using head space–gas chromatography technique

Abstract

Good Manufacturing practices (GMP) conditions command to check the levels of residual solvents, in order to sufficiently control the quality of APIs. Organic solvents such as Methanol, Acetone, Isopropyl alcohol (IPA), Hexane, Benzene, Toluene, and chlorobenzene are often utilized in pharmaceutical industry to manufacture Active Pharmaceutical Ingredients (APIs). A selective Gas Chromatography (GC) - Head space (HS) Injection system is applied for developing and validating the method for identification and quantification of residual solvents in Phenazopyridine Hydrochloride (PPH) drug as per International conference on Harmonization (ICH) guidelines. GC with Head space sampler and a Flame ionization detector were used to monitor residual solvents in APIs. The separation was carried out on ZB-624 capillary column. As carrier gas, Nitrogen was taken in Head space method. The method is proved to be simple, accurate, precise, sensitive, robust, reliable, reproducible and linear for the Identification and quantification of Methanol, Acetone, IPA, Hexane, Benzene, Toluene, chlorobenzene in PPH drug.