Analytical Method for the Simultaneous Determination of Albendazole and Metabolites Using HPLC-PDA: A Validation...

Area of Science:

• Analytical Chemistry
• Pharmacology
• Veterinary Medicine

Background:

• Albendazole is a crucial anthelmintic medication used in both human and veterinary medicine to treat nematode infections.
• Accurate quantification of albendazole and its primary metabolites (albendazole sulfoxide and albendazole sulfone) in biological matrices like plasma is essential for therapeutic drug monitoring and pharmacokinetic studies in cattle.

Purpose of the Study:

• To develop and validate a sensitive, accurate, precise, and efficient high-performance liquid chromatography (HPLC) method for the simultaneous determination of albendazole and its metabolites in cattle plasma.

Main Methods:

• A solid-phase extraction (SPE) procedure was employed for sample preparation.
• Chromatographic separation was achieved using an XBridge® C18 column with a gradient elution system comprising acetonitrile and an ammonium acetate buffer (0.025 M, pH 6.6).
• Detection was performed using a photodiode array (PDA) detector set at 292 nm, with a flow rate of 1.2 mL/min.

Main Results:

• The developed HPLC method demonstrated linearity over the concentration range of 0.025 to 2.0 µg/mL for all three analytes, with correlation coefficients (r²) exceeding 0.99.
• The method achieved satisfactory precision and accuracy at the lower limit of quantification (LLOQ), with coefficients of variation (CV) ≤ 15.1% and bias ≤ 17.7%.
• All validation parameters met the stringent criteria outlined by the European Medicines Agency (EMA) guideline (EMA/CHMP/ICH/172948/2019).

Conclusions:

• The developed HPLC method is a reliable, sensitive, and efficient tool for the simultaneous quantification of albendazole and its metabolites in cattle plasma.
• This validated method supports effective therapeutic drug monitoring and pharmacokinetic research in veterinary applications, ensuring optimal use of albendazole in cattle.