Determination of six residual solvents in bromhexine hydrochloride for injection by headspace gas chromatography
A headspace gas chromatography method was established for the determination of six residual solvents including ethanol,acetone,methylene chloride,ethyl acetate,n-hexane and toluene in bromhexine hydrochloride for injection,checking the solvent residue of some marketed bromhexine hydrochloride in China.The study was achieved on a HP-5 capillary column and the effects of equilibrium temperature and equilibrium time on separation were investigated and verified by methods.The results showed that the six solvents could be completely separated with good linear relationships(r＞0.999 0)in their re-spective concentration ranges.The limits of detection and quantitation of the 6 residual solvents were 0.024-0.400 μg/mL and 0.039-1.210 μg/mL,respectively.And the spiked recoveries were in the range of 85.0%-119.2%.It can be seen that this method is simple,sensitive and accurate,which could be used for the determination of 6 residual solvents in bromhexine hy-drochloride for injection.
Headspace gas chromatographyBromhexine hydrochloride for injectionResidual solvent
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