Photostability and Hydrolytic Forced Degradation Study of Albendazole: Validation of a Stability Indicating UV Spectroscopic Method Using Methanol

Abstract

Aim/Background: Albendazole (ABZ), a potent anthelmintic, is used against parasitic infections like giardiasis, trichuriasis and ascariasis. Forced degradation (FD) study was used to analyse the stability of drugs under stressful conditions such as elevated temperature, humidity, light, pH changes, oxidation and hydrolytic conditions. These studies determine the degradation pathways of any drug and it increases an interest to develop methods to ensure the safety as well as the efficacy of drug. The goal of this work was to develop and validate a UV Spectroscopic technique for ABZ’s FD analysis using methanol.

Materials and Methods: The instrument utilized for method development was UV-Visible Spectrophotometer (Shimadzu UV-1900i) and validated as per ICH guidelines, while Sodium Hydroxide (NaOH), Hydrochloric acid (HCl) and Hydrogen Peroxide (H₂O₂) induced FD studies were carried out under various conditions.

Result: The maximum absorbance of ABZ was at 295nm, with linearity (R²) of 0.9994. Validation studies demonstrated accuracy and precision with a percentage relative standard deviation (RSD) of lower than 2%. ABZ underwent degradation under hydrolysis and oxidative conditions. Aqueous hydrolysis of the drug shows 59.73% degradation, while acid hydrolysis showed 28.35% degradation, 18.38% degradation in alkaline hydrolysis and 35.12% in oxidative condition.

Conclusion: This study demonstrates a reliable, sensitive and straight forward analytical method for evaluating ABZ's FD using UV Spectroscopy. The ABZ drug substance showed degradation at hydrolysis and oxidative conditions. Thermal and photolytic stress had no impact on stability of ABZ.