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

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dc.contributor.authorPrafull Mathur
dc.contributor.authorSuvigya Mathur
dc.contributor.authorAnand Kumar Mishra
dc.contributor.authorTanaji Kunjir
dc.date.accessioned2025-12-15T09:14:43Z
dc.date.available2025-12-15T09:14:43Z
dc.date.issued2013-11
dc.description.abstractThe 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 bromhexine hydrochloride (BHX) active pharmaceutical ingredient (API). This paper describes the development and validation of a simple, efficient, accurate, and robust static headspace gas chromatography method for the determination of residual solvents, namely methanol, ethanol, ethyl acetate, monochlorobenzene, and benzene, in BHXAPI. This new method has been demonstrated to be accurate, linear, precise, reproducible, specific, and robust for its intended purpose. The method gives 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 strongly indicate that this method can be readily used to determine residual solvents in BHX.
dc.identifier.issn2321-2217
dc.identifier.issn2321-2225
dc.identifier.otherhttps://doi.org/10.15415/jptrm.2013.12014
dc.identifier.urihttps://demodspace.chitkara.edu.in/handle/123456789/162
dc.language.isoen
dc.publisherChitkara University Publications
dc.subjectResidual solvents
dc.subjectStatic Headspace Gas chromatography
dc.subjectMethod Validation
dc.subjectBromhexine hydrochloride
dc.subjectActive pharmaceutical ingredient (API)
dc.titleDevelopment and Validation of Static HS-GC Method for the Determination and Quantification of Residual Solvents of Bromhexine Hydrochloride (BHX)
dc.typeArticle

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JPTRM Vol. 1 No. 2 (November 2013)