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The determination of residual solvents in drug substances is the mandatory requirement by various health authorities in the world. There are no analytical methods available in the literature that can simultaneously separate and quantitate residual solvents in bromohexine hydrochloride (BHX) active pharmaceutical ingredient (API). This paper describes the developmentand validation of a simple, efficient, accurate and robust static headspace gas chromatography method forthe determination of residual solvents, namely methanol, ethanol, ethyl acetate, monochlorobenzene and benzene, in BHXAPI.This new method has been demonstrated to beaccurate, linear, precise, reproducible, specific and robust for its intended purpose.The method give very good sensitivities viz. detection limits for benzene is 0.4 ppm, ethyl acetate 2 ppm and for others solvents 5 ppm and precision (below 9.0 % RSD) for all solvents. The results of this evaluation stronglyindicate that this method can be readily used to determine residual solvents in BHX.

Development and Validation of Static HS-GC Method for the Determination and Quantification of Residual Solvents of Bromhexine Hydrochloride (BHX)