Quality analysis of albendazole formulations available in veterinary pharmacies of Nepal.

backgroundEcto- and endoparasites cause significant economic losses to the livestock industry, primarily due to helminth parasites. The heavy reliance on anthelmintics to control parasites, coupled with inadequate drug quality in terms of physical and content parameters, often leads to excessive and irrational use of anthelmintics. This poses a public health hazard due to the potential development of anthelmintic resistance. The dosage prescribed depends on the active ingredients present in the drug. Thus, an anthelmintic drug must contain the labeled amount of active pharmaceutical ingredients and comply with the standard quality tests. Veterinary Standards and Drug Regulatory Laboratory (VSDRL) is the national regulatory laboratory of Nepal for veterinary products, mandated to test the quality of various veterinary drugs. Amidst growing concerns of anthelmintic resistance and constant rumors of ineffectiveness of anthelmintics in the Nepalese market, it is vital to analyze the quality of veterinary drugs in Nepal. This study aims to analyze the quality (physical and content analysis) of albendazole drug available in the local market and to aware the general public, veterinary practitioners, and policy makers.

methodsWe conducted the study from July 2021 to July 2023 at VSDRL in Kathmandu. A total of 118 samples of albendazole drug (suspension of 25 mg/ml, tablets of 200 mg and 300 mg, and boluses of 600 mg and 1500 mg) were collected from seven different pharmaceuticals across 20 districts of Nepal. The samples were tested for their physical conformity and assay according to the laboratory protocols of VSDRL. Physical analysis included weight variation, hardness, friability, and disintegration, whereas the content analysis was performed using UV spectrophotometry and High-performance liquid chromatography (HPLC). Data were entered and analyzed using MS Excel and visualized with R.

resultsAll samples complied with standard limits for weight variation, disintegration time ( < 15 min), and API content (tablets/boluses: 92.5–107.5%; suspension: 90–110%). However, only 46% and 20% of tablets/boluses of company B and A respectively, met the standard hardness range (5–10 kg/cm2). Most of the samples had higher hardness than the standard limit, although all samples complied with the standard disintegration time. Friability compliance varied with highest percentage of compliance of company C. However, the Fisher’s Exact Test did not show a significant association between companies and friability compliance (p = 0.379).

conclusionThus, it is necessary to routinely monitor the quality of veterinary drugs to ensure that they are manufactured and supplied to the market as per the recommended standards, thereby safeguarding both animal and public health.