A Validated Stability-Indicating RP-HPLC Method for Albendazole in Pharmaceutical Finished Products Stability-Indicating RP-HPLC Assay of Albendazole
Iranian Journal of Pharmaceutical Sciences,
Vol. 22 No. 1 (2026),
26 January 2026
,
Page 259-271
https://doi.org/10.22037/ijps.v22i1.50419
Abstract
The study objective is to develop a rapid, isocratic, simple, and precise high-performance liquid chromatography (HPLC) method for quantifying albendazole in pharmaceutical dose form and bulk available in Bangladesh. A Shim-pack C18 column (250 × 4.6 mm, 5 µm) was used to separate albendazole at a detection wavelength of 235 nm. The mobile phase consisted of a 30:70% v/v mixture of methanol and a 0.2% orthophosphoric acid buffer, pumped at 1.0 ml/min. Acidic, basic, oxidative, photolytic, and thermal degradation at 50 ºC, 60 ºC, and 80 ºC for 1 to 3 hr for albendazole as per ICH Q1A (R2). The recovery level was 98.92 % - 101.68 %. Relative standard deviation (RSD) was below 5%. All the validation parameters were found to be within the limits according to International Conference on Harmonization (ICH) guidelines. Basic, Oxidative, and thermal degradation at 80 ºC vary from 5.08%- 13.89%, 5.84%-25.06%, and 7.96%-15.58%respectively for 1 to 3 hr. Mild impairment of the drug was observed for acidic, thermal at 50 ºC, 60 ºC, and photolytic degradation, and while moderate degradation occurred under basic, oxidative, and thermal conditions at 80 ºC. The batch-to-batch recovery variability of 98.9% to 100.4% for all the brands indicates excellent manufacturing consistency.
- Albendazole
- Method validation
- Stressed degradation study
How to Cite
References
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