Unveiling cloperastine fendizoate degradation using MS/MS: A novel HPLC method for simultaneous analysis with parabens and degradant characterization

Document Type

Article

Publication Date

10-2025

Abstract

Background

Environmental considerations are gaining a worthy role in the effective evaluation of analytical approaches. Cloperastine fendizoate (CLOP), an antitussive with antihistaminic activity, requires for developing and validating a novel green HPLC technique to be measured in presence of paraben, and CLOP degradation products.

Methods

The proposed method is constructed through a C18 column using a mobile phase, that includes ethanol and 0.1% orthophosphoric acid (pH= 4) at 50:50 v/v ratio, with flow rate equal to 1.0 mL/min. UV detection was employed at 250.0 nm. This method was successfully applied for the analysis of CLOP suspension formulation (Notussil®), confirming its determination.

Results

CLOP showed degradation of 22.86 % under basic, 20.68 % under acidic, and 12.86 % under oxidative conditions after 45 minutes. MS/MS analysis obtained a major degradant with an m/z of 105.03, corresponding to benzaldehyde formed via ether bond cleavage under all stress conditions. The current method was fully validated through ICH guidelines, Demonstrating a concentration range of 5.0–200.0 µg/mL as a good linearity. A mean percentage recovery of 100.43 ± 0.148% was calculated to verify accuracy. Through comparing the existing method, no significant differences were detected. CLOP degradation under various stress conditions was studied to highlight the importance of stability testing. This method was further evaluated by quantitative evaluation using AGREE and WAC tools.

Conclusion

The proposed method offers environmental benefits through reduced hazardous chemicals, energy, and waste, which showed the method’s high greenness score and maintained performance across analytical, environmental, and practical criteria.

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