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.

RP-HPLC stability-indicating method for simultaneous determination of sodium valproate, methylparaben and propylparaben in oral solution

“…1b), with a molecular weight of 180.2 g/mol [1]. Both MP and PP are members of Parabens group which are commonly used as preservatives in pharmaceutical formulation, as well as food and cosmetic products due to their anti-fungal and antibacterial activity [2,3]. The parabens proved efficiency over a wide pH range [4].…”

“…MP and PP were assayed by titration methods in USP which require a long time for sample preparation [6]. Parabens were assayed by RP-HPLC methods in pharmaceutical products and cosmetics [3,5,[7][8][9].…”

A Facile HPLC-PDA Method for Simultaneous Determination of Paracetamol, Methyl Paraben, Sunset Yellow and Carmosine in Oral Suspensions

“…In this respect, we focused on simultaneous high performance liquid chromatography (HPLC) determination of the single drug, paracetamol, along with colorants, sunset yellow and carmoisine, and preservative, methyl paraben, in pediatric oral suspension samples that belong to the same pharmaceutical company, in this study. Many analytical methods, either for single or combination with other analytes in various matrices, have been described in the literature for determination of paracetamol (16,17), methyl paraben (18,19), sunset yellow (20,21) and carmoisine (22,23) by HPLC in particular. However, no method describes quantification of this drug and color and preservative additives simultaneously.…”

A simple and rapid HPLC method for determination of parabens and their degradation products in pharmaceutical dosage forms

“…benzoic acid (PHB), in terms of the determination of its parent preservatives along with the degradation products liberated throughout the stability cycle. Based on the agency requirement to develop a stability-indicating method, literature search reveals that few LC methods were published in general food and cosmetic applications (Kumar et al, 2011;Saad et al, 2005 and drug substance/drug product determination (H ajkov a et al, 2003;Tsvetkova & Peikova, 2014;Kumar et al, 2012;Ali et al, 2006;El-Hay et al, 2016;Bachute et al, 2012;Roy & Chakrabarty, 2013;Shabir, 2010;Kreuz et al, 1999. And few were published in micellar electrokinetic chromatography (Safra & Pospisilova, 2008) and capillary electrophoresis techniques (Uysal & Güray, 2008;Lee et al, 2013 and human urine determination by LC-MS/MS.…”