Method Development and Validation of High Performance Liquid Chromatography Method for Methylparaben and Butylparaben in Ointment Form

Gunasekar Manoharan , Ramadan Abdel Wahed Mohamed


The main aim of this study was to investigate the performance of development method for methylparaben and butylparaben determination in skin ointment product by High Performance Liquid Chromatography (HPLC). The method validation parameters were evaluated as per International Conference on Harmonisation (ICH) Guidelines. The method shows the specificity has retention time of methylparaben and butylparaben at 2.10 minutes and 6.64 minutes, respectively. The mobile phase had acetonitrile, methanol and phosphate buffer with the ratio of 10:40:50 v/v. The flow rate was set as 1 ml/minute and the maximum absorption was observed at 270 nm using Shimadzu SPD-20A Prominence UV-Visible detector. Correlation coefficient values are 0.9998 and 0.9996, respectively. The specificity, linearity, accuracy (established by % recovery), precision (repeatability and intermediate precision), the sensitivity (limit of detection and limit of quantitation), and robustness were validated for methylparaben and butylparaben in skin ointment product. The validation results fulfilled the acceptance criteria of validation method based on ICH Guideline.

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