Development and application of a spectrophotometric method in quality evaluation of benzimidazole anthelminthics in Nairobi city county

Abstract

Abstract Background 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. Results 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. Conclusion 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.