Indirect Spectrophotometric Method for Determination of Bromhexine-HCl in Pharmaceutical Preparations

Abstract

A simple, accurate and sensitive spectrophotometric method for determination of bromhexine-HCl in aqueous solution has been described. The proposed method is based on the reduction of cerium (Іν) in acidic medium into cerium (Ш) by the drug followed by the complex formation of cerium (Ш) with arsenazo Ш to form a greenish-blue water soluble, stable complex that has a maximum absorbance at 651nm against the reagent blank. Beer's law is obeyed in the range of 10 to 200µg of bromhexine-HCl /20 ml (i.e. 0.5-10 ppm) with molar absorptivity of 1.48×10 4 l.mol-1. cm-1 and a good determination coefficient (R 2 =0.9978). The limit of detection (LOD) and limit of quantification (LOQ) are 0.408 and 1.394µg ml −1 , respectively. The relative error and a relative standard deviations are found in the range-0.354 to1.93 % and ± 0.135 to ± 1.033%, respectively, depending on the concentration level. The method is suitable for the determination of bromhexine-HCl in the presence of other ingredients that are usually present in dosage forms. This procedure is applied successfully for the analysis of bromhexine-HCl in pharmaceutical preparations (tablets, syrup and injection) without prior separation and with acceptable errors. ‫ﻁﻴﻔﻴﺔ‬ ‫ﻁﺭﻴﻘﺔ‬ ‫ﻤﺒﺎﺸﺭﺓ‬ ‫ﻏﻴﺭ‬ ‫ﻟﺘﻘﺩﻴﺭ‬ ‫ﺍ‬ ‫ﻟﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬-HCl ‫ﻓﻲ‬ ‫ﺍﻟ‬ ‫ﺍﻟﺼﻴﺩﻻﻨﻴﺔ‬ ‫ﻤﺴﺘﺤﻀﺭﺍﺕ‬ ‫ﺍﻟﻤﻠﺨﺹ‬ ‫ﻭ‬ ‫ﺒﺴﻴﻁﺔ‬ ‫ﻁﻴﻔﻴﺔ‬ ‫ﻁﺭﻴﻘﺔ‬ ‫ﻭﺼﻑ‬ ‫ﺘﻡ‬ ‫ﺩﻗﻴﻘﺔ‬ ‫ﺍﻟﺒﺭﻭﻤﻬ‬ ‫ﻟﺘﻘﺩﻴﺭ‬ ‫ﻭﺤﺴﺎﺴﺔ‬ ‫ﻜﺴﻴﻥ‬ ‫ﺒﻌﺽ‬ ‫ﻓﻲ‬ ‫ﺍﻟﺼﻴﺩﻻﻨﻴﺔ‬ ‫ﺍﻟﻤﺴﺘﺤﻀﺭﺍﺕ‬. ‫ﺍﻟﻁﺭﻴﻘﺔ‬ ‫ﺘﻌﺘﻤﺩ‬ ‫ﺍﻟﺤﺎﻤﻀﻲ‬ ‫ﺍﻟﻭﺴﻁ‬ ‫ﻓﻲ‬ ‫ﺍﻟﺭﺒﺎﻋﻲ‬ ‫ﺍﻟﺴﻴﺭﻴﻭﻡ‬ ‫ﺒﻭﺍﺴﻁﺔ‬ ‫ﺍﻟﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬ ‫ﺃﻜﺴﺩﺓ‬ ‫ﻋﻠﻰ‬ ‫ﺘﻔﺎﻋل‬ ‫ﺜﻡ‬ ‫ﺍﻵﺭﺴﻴﻥ‬ ‫ﻜﺎﺸﻑ‬ ‫ﻤﻊ‬ ‫ﺍﻟﻨﺎﺘﺞ‬ ‫ﺍﻟﺜﻼﺜﻲ‬ ‫ﺍﻟﺴﻴﺭﻴﻭﻡ‬ ‫ﺁﺯﻭ‬ Ш ‫ﻟ‬ ‫ﺘ‬ ‫ﻜﻭ‬ ‫ﻴ‬ ‫ﻤﻌﻘﺩ‬ ‫ﻥ‬ ‫ﺍﺯﺭﻕ‬ ‫ﻟﻭﻥ‬ ‫ﺫﻱ‬-‫ﻤﺨﻀﺭ‬ ، ‫ﻤﺴﺘﻘﺭ‬ ‫ﻭ‬ ‫ﺍﻟﻤﺎﺀ‬ ‫ﻓﻲ‬ ‫ﺫﺍﺌﺏ‬ ‫ﻟﻪ‬ ‫ﺃﻋﻠﻰ‬ ‫ﺍﻤﺘﺼﺎﺹ‬ ‫ﺍﻟﻤﻭﺠﻲ‬ ‫ﺍﻟﻁﻭل‬ ‫ﻋﻨﺩ‬ 651 ‫ﻗﻴﻤﺔ‬ ‫ﻭﻜﺎﻨﺕ‬ ‫ﺍﻟﺼﻭﺭﻱ‬ ‫ﺍﻟﻤﺤﻠﻭل‬ ‫ﻤﻘﺎﺒل‬ ‫ﻨﺎﻨﻭﻤﻴﺘﺭ‬ ‫ﺍﻻﻤﺘﺼﺎﺼﻴﺔ‬ ‫ﺍﻟﻤﻭﻻﺭﻴﺔ‬ 1.48 x 10 4 ‫ﻟ‬ ‫ﺘﺭ‬. ‫ﻤﻭل‬ 1-. ‫ﺴﻡ‬ 1-. ‫ﺒﻴﺭ‬ ‫ﻗﺎﻨﻭﻥ‬ ‫ﺤﺩﻭﺩ‬ ‫ﻭﻜﺎﻨﺕ‬ ‫ﺍﻟﺘﺭﻜﻴﺯ‬ ‫ﻤﺩﻯ‬ ‫ﻀﻤﻥ‬ 200-10 ‫ﻨﻬﺎﺌﻲ‬ ‫ﺤﺠﻡ‬ ‫ﻓﻲ‬ ‫ﺍﻟﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬ ‫ﻤﻥ‬ ‫ﻤﺎﻴﻜﺭﻭﻏﺭﺍﻡ‬ 20 ‫ﻤﻠﻠﺘﺭ‬) ‫ﺃﻱ‬ 0.5-10 ‫ﺠﺯﺀ‬ / ‫ﻤﻠﻴﻭﻥ‬ .(‫ﻗﻴﻤﺔ‬ ‫ﻭﻜﺎﻨﺕ‬ ‫ﺍﻟﺘﻘﺩﻴﺭ‬ ‫ﻤﻌﺎﻤل‬ 0.9978. ‫ﺍﻟﺨ‬ ‫ﻗﻴﻡ‬ ‫ﻜﺎﻨﺕ‬ ‫ﺒﻴﻥ‬ ‫ﺘﺘﺭﺍﻭﺡ‬ ‫ﻟﻠﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬ ‫ﺍﻟﻨﺴﺒﻲ‬ ‫ﻁﺄ‬ 0.354-‫ﻭ‬ 1.93 % ‫ﺍﻟﻨﺴﺒﻲ‬ ‫ﺍﻟﻘﻴﺎﺴﻲ‬ ‫ﻭﺍﻻﻨﺤﺭﺍﻑ‬ ‫ﻤﻥ‬ ± 0.135 ‫ﺇﻟﻰ‬ %1.033 ± ‫ﺍﻋﺘﻤﺎﺩﺍ‬ ‫ﺍﻟﺘﺭﻜﻴﺯ‬ ‫ﻤﺴﺘﻭﻯ‬ ‫ﻋﻠﻰ‬ ‫ﺒﺩﻗﺔ‬ ‫ﺘﻤﺘﺎﺯ‬ ‫ﺍﻟﻁﺭﻴﻘﺔ‬ ‫ﺃﻥ‬ ‫ﻋﻠﻰ‬ ‫ﻴﺩل‬ ‫ﻤﻤﺎ‬ ‫ﻟﻠﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬ ‫ﻋﺎﻟﻴﺘﻴﻥ‬ ‫ﻭﻤﻀﺒﻭﻁﻴﺔ‬ ، ‫ﻭ‬ ‫ﺒﻠﻐﺕ‬ ‫ﺍﻟﻜﺸﻑ‬ ‫ﺤﺩ‬ ‫ﻗﻴﻤﺔ‬ (LOD) ‫ﺍﻟﻜﻤﻲ‬ ‫ﺍﻟﺘﻘﺩﻴﺭ‬ ‫ﺤﺩ‬ ‫ﻭﻗﻴﻤﺔ‬) LOQ (‫ﻟﻠﻁﺭﻴﻘﺔ‬ 0.408 ‫ﻭ‬ 1.394 ‫ﻤﺎﻴﻜﺭﻭﻏﺭﺍﻡ‬. ‫ﻤﻠﻠﺘﺭ‬-1 ‫ﺍﻟﺘﻭﺍﻟﻲ‬ ‫ﻋﻠﻰ‬. ‫ﺍﻟﺩﻭﺍﺌﻴﺔ‬ ‫ﺍﻷﻗﺭﺍﺹ‬ ‫ﻓﻲ‬ ‫ﺍﻟﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬ ‫ﻟﺘﻘﺩﻴﺭ‬ ‫ﺒﻨﺠﺎﺡ‬ ‫ﺍﻟﻁﺭﻴﻘﺔ‬ ‫ﻁﺒﻘﺕ‬ ‫ﻭﻗﺩ‬ ‫ﻭ‬ ‫ﺍﻟﺸﺭﺍﺏ‬ ‫ﻭﺍﻟﺤﻘﻥ‬. ‫ﺍﻟﺩﺍﻟﺔ‬ ‫ﺍﻟﻜﻠﻤﺎﺕ‬ : ‫ﺒﺭﻭﻤﻬﻜﺴﻴﻥ‬-HCl ، ‫ﺍﻟﺭﺒﺎﻋﻲ‬ ‫ﺍﻟﺴﻴﺭﻴﻭﻡ‬ ، ‫ﺁﺯﻭ‬ ‫ﺍﻵﺭﺴﻴﻥ‬ Ш ‫ﻭﺍﺨﺘﺯﺍل‬ ‫ﺍﻜﺴﺩﺓ‬ ،. ‫ـــــــــــــــــــــــــــــــــــــ‬ ‫ــــــــــــــــــــــــــــ‬