title: Development and validation of a single RP-HPLC assay method for analysis of bulk raw material batches of four parabens that are widely used as preservatives in pharmaceutical and cosmetic products.
abstract: A stability-indicating, robust, fast, and user friendly reversed-phase high-performance liquid chromatographic (RP-HPLC) assay method has been developed and validated for the analysis of commercial raw material batches of methylparaben, ethylparaben, propylparaben, and butylparaben. These four parabens are widely used as preservatives in pharmaceutical and cosmetic products. Accurate assay value of each of the parabens in their respective commercial lots is critical to determine the correct weight of the paraben that is needed to obtain the target concentration of the paraben in a specific lot of pharmaceutical or cosmetic products. Currently, there are no single HPLC assay methods (validated as per ICH requirements) available in the literature that can be used to analyze the commercial lots of each of the four parabens. The analytical method reported herein analyzes all four parabens in less than 10 min. The method presented in this report was successfully validated as per ICH guidelines. Therefore, this method can be implemented in QC laboratories to analyze and assay the commercial bulk lots of the four parabens.
authors.affiliation: Global Quality Services-Analytical Sciences, Merck & Co., Inc., 1011 Morris Avenue, Union, NJ 07083, USA. satish.kumar2@merck.com
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.forename: S
authors.initials: S
authors.lastname: Mathkar
authors.forename: C
authors.initials: C
authors.lastname: Romero
authors.forename: A M
authors.initials: AM
authors.lastname: Rustum
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D056148:Chromatography, Reverse-Phase / Q000379:methods* / Q000592:standards; D003358:Cosmetics / Q000032:analysis; D004355:Drug Stability; D016018:Least-Squares Analysis; D010226:Parabens / Q000032:analysis*; D011310:Preservatives, Pharmaceutical / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D003358:Cosmetics; D010226:Parabens; D011310:Preservatives, Pharmaceutical