Arayne M Saeed, Sultana Najma, Siddiqui Farhan Ahmed
Department of Chemistry, University of Karachi, Karachi-75270, Pakistan.
Pak J Pharm Sci. 2005 Apr;18(2):11-4.
A simple, sensitive, selective, reliable, least time consuming and rapid high-performance liquid chromatographic method for the determination and quantification of mebeverine hydrochloride using hyoscine butylbromide as internal standard has been developed. The chromatographic system consisted of a Shimadzu LC-10 AT VP pump, SPD-10 AV VP UV visible detector, and a CBM-102 Bus Module integrator. Separation was achieved on the micro Bondapak 125 a C18 10microm column at room temperature. The samples were introduced through an injector valve with a 10 microl sample loop. Acetonitrile-water (1:1 v/v) was used as mobile phase, with flow rate 1.7 ml/minutes. pH was adjusted to 2.9 with phosphoric acid. U.V detection was performed at 205 nm. The results obtained showed a good agreement with the declared content. Recovery values of mebeverine hydrochloride were from 99.80% to 100.13%. The proposed method is rapid, accurate, and selective and may be used for the quantitative analysis of mebeverine hydrochloride. The method was found to be specific, accurate, precise and reliable for the determination and quantification of mebeverine hydrochloride in form of raw materials, in bulk drugs and formulation. It was possible to determine all of them in the concentration range of 5-30 nano grams. The detection limit of mebeverine hydrochloride was 0.4-nano gram.
已开发出一种简单、灵敏、选择性好、可靠、耗时最少且快速的高效液相色谱法，以丁溴东莨菪碱为内标物，用于测定和定量盐酸美贝维林。色谱系统由岛津LC - 10 AT VP泵、SPD - 10 AV VP紫外可见检测器和CBM - 102总线模块积分仪组成。在室温下，于微Bondapak 125 a C18 10微米柱上实现分离。样品通过带有10微升样品环的进样阀引入。乙腈 - 水（1:1 v/v）用作流动相，流速为1.7毫升/分钟。用磷酸将pH调节至2.9。在205纳米处进行紫外检测。所得结果与申报含量吻合良好。盐酸美贝维林的回收率为99.80%至100.13%。所提出的方法快速、准确且具有选择性，可用于盐酸美贝维林的定量分析。该方法被发现对于测定和定量原料药、散装药品及制剂形式的盐酸美贝维林具有特异性、准确性、精密度和可靠性。在5 - 30纳克的浓度范围内能够测定所有这些物质。盐酸美贝维林的检测限为0.4纳克。
