Development and validation of a Reverse Phase - High Performance Liquid Chromatography (RP-HPLC) method for simultaneous quantification of bronopol, sodium benzoate, methylparaben, and propylparaben in Vasu Zeal kid drops

Abstract

Background: Achieving a balanced mixture with the right preservative concentration is most crucial part to maintain the stability of a product and its shelf life. Objective: The objective is to employ a sensitive method for accurate determination of all preservatives namely, bronopol, sodium benzoate, methylparaben, and propylparaben in antitussive kid drops (Zeal Kid Drops). Materials and Methods: The method was successfully developed and validated with the reference to the International Council for Harmonization (ICH) guidelines. All the analytes were separated within 30 min on column C18 (5 μm, 4.6 mm × 250 mm) using mobile phase; phosphate buffer: acetonitrile (65:35) at 40°C, in isocratic mode, and flow rate was 1 mL/min. Method validation was assessed as per ICH Q2(R2) guideline. Results: Bronopol, sodium benzoate, methylparaben, and propylparaben were quantified, and percentage of preservatives was 0.015, 0.483, 0.201 and 0.037, respectively, using developed method. Specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification were established and found within the acceptable range. Conclusion: The developed Reverse Phase - High Performance Liquid Chromatography (RP-HPLC) method is simple, precise, and accurate; making it suitable for utilization as a quality control tool for liquid oral formulations.

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