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Development and application of a spectrophotometric method in quality evaluation of benzimidazole anthelminthics in Nairobi city county
Future Journal of Pharmaceutical Sciences Pub Date : 2020-10-20 , DOI: 10.1186/s43094-020-00103-4
Johnson K. Murage , Beatrice K. Amugune , Peter Njogu , Stanley Ndwigah

Neglected tropical diseases (NTDs) are a group of communicable diseases which are prevalent in the tropics affecting more than one billion people. Treatment and prevention of these infections is very costly to developing economies. Helminthiases are classified among NTDs. The communities afflicted are poor and have limited access to essential resources for their livelihood. Poor-quality drugs for NTDs may lead to death or prolonged treatment without achieving the desired results. The limited resources used in purchasing poor-quality drugs will therefore be wasted instead of being put to good use. Most of the methods available for the analysis of benzimidazole anthelminthics utilize high-performance liquid chromatography. They are therefore time consuming, require sophisticated and expensive equipment, utilize rare and expensive reagents and solvents, and call for skilled personnel. A simple, rapid, and inexpensive ultraviolet spectrophotometric method of analysis would therefore come in handy especially in the analysis of many samples as occurs during post-authorization market surveillance for quality. The suitable solvent for the spectroscopic analysis was established as 0.1 M methanolic HCl. The wavelength of analysis was set at 294 nm. Upon validation, the method was found to have good linearity. The range over which linearity was established was way beyond the 80 to 120% of the working concentration specified by the ICH. The method exhibited good precision. Out of 32 commercial samples analyzed, five (15.6%) did not comply with compendial specifications. Intra-brand batch variation was also observed. Out of three batches of product A002T analyzed, one did not comply with compendial specifications. A major limitation in the analysis of benzimidazole anthelminthics is the lack of reliable, simple, rapid, and low-cost methods of analysis with high throughput. The developed method serves to fill this gap. It can be used in the analysis of raw materials and finished products. It can also be used in the establishment of the quality of products prior to registration. The method will prove very useful in post-market surveillance of quality of benzimidazole anthelminthics.

中文翻译:

分光光度法在内罗毕市县苯并咪唑类驱虫药质量评价中的开发与应用

被忽视的热带病(NTD)是一类传染性疾病,在热带地区十分普遍,影响了超过十亿人口。这些感染的治疗和预防对发展中经济体而言是非常昂贵的。蠕虫病被分类为NTD。受影响的社区是贫穷的,他们赖以生存的基本资源有限。用于NTD的劣质药物可能导致死亡或长期治疗,而未达到预期的效果。因此,用于购买劣质药品的有限资源将被浪费,而不是被善加利用。用于分析苯并咪唑类驱虫药的大多数方法都使用高效液相色谱法。因此,它们很耗时,需要复杂且昂贵的设备,使用稀有且昂贵的试剂和溶剂,并要求熟练的技术人员。因此,一种简单,快速且便宜的紫外分光光度法分析方法将派上用场,特别是在对授权后市场进行质量监控期间对许多样品进行分析时。用于光谱分析的合适溶剂为0.1 M HCl甲醇。分析波长设定为294nm。经验证,发现该方法具有良好的线性。建立线性度的范围远远超出ICH指定的工作浓度的80%至120%。该方法显示出良好的精度。在分析的32个商业样本中,有五个(15.6%)不符合药典规范。还观察到品牌内批次变化。在分析的三批次产品A002T中,有一个不符合药典规范。苯并咪唑类驱虫药分析的主要限制是缺乏可靠,简单,快速和低成本的高通量分析方法。所开发的方法可填补这一空白。可用于原料和成品的分析。在注册之前,它也可以用于确定产品质量。该方法将在对苯并咪唑类驱虫药质量进行上市后监测中非常有用。可用于原料和成品的分析。在注册之前,它也可以用于确定产品质量。该方法将在对苯并咪唑类驱虫药质量进行上市后监测中非常有用。可用于原料和成品的分析。在注册之前,它也可以用于确定产品质量。该方法将在对苯并咪唑类驱虫药质量进行上市后监测中非常有用。
更新日期:2020-10-21
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