European Journal of Biomedical and Pharmaceutical Sciences

A GREEN ANALYTICAL STABILITY INDICATING RP HPLC METHOD FOR THE QUANTIFICATION OF CLOBAZAM RELATED IMPURITIES IN ORAL SUSPENSION DOSAGE FORM

Ravi Kiran Kaja, Prasanna Ravi Kanth Konduri, Giridhar Kunamaneni, Pranitha Sambu,
Anjaneyulu Vinukonda*

ABSTRACT

A green and eco-friendly high-resolution HPLC method was developed for the quantification of impurities   in Clobazam oral suspension dosage forms. The stability-indicating method achieved effective separation and quantification of degradation-related impurities with acceptable peak resolution while reducing organic solvent consumption. Chromatographic separation was achieved on a Zorbax SB-C8 column (250 × 4.6 mm, 5.0 µm) using 10 mM sodium phosphate buffer (pH 7.0) and acetonitrile under gradient elution conditions. The flow rate was maintained at 1.2 mL/min, column temperature at 30 °C, and UV detection was carried out at 230 nm. The developed method provided adequate resolution between Clobazam and its related impurities with excellent specificity. Linearity was established over the concentration range of 0.2000–2.000 µg/mL with correlation coefficients (R²) greater than 0.999. The method demonstrated acceptable accuracy, with recoveries exceeding 97%, and satisfactory precision in accordance with ICH guidelines. The LOD and LOQ values confirmed the sensitivity of the method for trace-level impurity quantification. Robustness studies indicated that minor deliberate variations in chromatographic conditions did not significantly affect method performance. Forced degradation studies under acidic and basic stress conditions confirmed the stability-indicating capability of the method. Green analytical assessment using Analytical Eco-Scale and GAPI tools indicated(0.82&86)good environmental sustainability and reduced solvent consumption, supporting its application for routine quality control and stability testing.

Keywords: Clobazam, HPLC, method development, Validation.