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A Robust Stability-Indicating RP-HPLC Method for Simultaneous Determination of Widely Used Pharmaceutical and
Ramanjaneyulu Seemaladinne1,2, Sudip Mandal1,3
1Department of Chemistry, School of Applied Sciences and Humanities, Vignan's Foundation for Science, Technology and Research, Guntur, Andhra Pradesh, India.
Biomedical Chromatography : BMC
|August 1, 2026
Summary
A new stability-indicating HPLC method accurately quantifies seven common pharmaceutical and cosmetic preservatives and their impurities. This validated analytical technique ensures product quality and safety throughout shelf life.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Science
- Cosmetic Science
Background:
- Preservatives are vital for pharmaceutical and cosmetic product stability and safety.
- Monitoring preservative quality is crucial due to their functional importance.
- Common preservatives include parabens, benzoic acid derivatives, and benzyl alcohol.
Purpose of the Study:
- To develop and validate a stability-indicating HPLC method for simultaneous quantification of seven preservatives and two impurities.
- To establish a reliable analytical technique for quality control of pharmaceutical and cosmetic products.
Main Methods:
- Development and validation of a reverse-phase high-performance liquid chromatography (RP-HPLC) method.
- Utilized a Phenomenex Luna C18 column with dual-wavelength UV detection (254 and 230 nm).
- Employed a gradient mobile phase of 0.1% orthophosphoric acid and acetonitrile.
Main Results:
- The method achieved high selectivity, sensitivity, accuracy, and precision.
- Quantification range established at 1.5-45.0 μg/mL for all nine components.
- Method validation met International Council for Harmonization (ICH) guidelines.
Conclusions:
- The validated HPLC method is suitable for routine quality control of pharmaceutical and cosmetic formulations.
- This method ensures the accurate assessment of preservative content and potential impurities.
- The developed technique supports the maintenance of product efficacy and safety.
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