Development and validation of a simultaneous analytical method for non‐steroidal therapeutic compounds in cosmetics using liquid chromatography–tandem mass spectrometry

Abstract

Atopic dermatitis is a typical chronic inflammatory skin disease that affects all age groups and requires basic skin care for treatment. Anti-inflammatory and antiallergy steroids are the most frequently used treatments but they are limited due to their side effects caused by a weakening of the immune system. Many consumers focus on performance as a criterion for selecting cosmetics. However, steroids have been illegally used to improve the performance of cosmetics, and consumers have been adversely affected by the corresponding side effects. In this paper, we propose a simple and rapid method using liquid chromatographytandem mass spectrometry to simultaneously analyze ten non-permitted atopic therapeutic compounds in cosmetic products: chlorpheniramine maleate, ketotifen fumarate, doxepin hydrochloride, azelastine hydrochloride, bufexamac, clotrimazole, tranilast, fusidic acid, tacrolimus, and pimecrolimus. Additionally, the major characteristic fragment ions for tacrolimus, pimecrolimus, and clotrimazole were identified by time-of-flight mass spectrometry. The specificity, linearity, limit of detection, limit of quantification, recovery, precision, accuracy, and stability of the proposed method were validated. The limit of detection and quantification were in the ranges of 5.05-203.30 pg/mL and 15.15-609.90 pg/mL, respectively. The proposed analysis method could help improve the safety management of cosmetics. K E Y W O R D Satopic dermatitis, illegal cosmetics, liquid chromatography tandem mass spectrometry, therapeutics, topical calcineurin inhibitors Abbreviations: AD, atopic dermatitis; Q-TOF-MS, quadrupole time of flight mass spectrometry; MRM, multiple reaction monitoring; TCI, topical calcineurin inhibitor INTRODUCTIONAtopic dermatitis (AD) refers to a chronic refractory inflammatory skin disease caused by a combination of genetic, environmental, and immunological factors of an

Development and Validation of HPTLC Method for Estimation of Pimecrolimus in Formulations

“…A suitable and validated method should be vacant for the drug delivery system for the analysis of bulk drug and in pharmaceutical cream formulation. Various methods are reported for the analysis of pimecrolimus alone or in combination with other drugs have been reported, which included, HPLC-MS/MS [3], RP-HPLC [2] and LC-TMS [4] but pimecrolimus has not yet been subject to the HPTLC method of analysis, as far as we are aware.…”

Characterization and determination of benvitimod, an unknown risk substance in cosmetics, using nuclear magnetic resonance spectroscopy and HPLC‒MS/MS

“…The risk compounds screened by the platform can further establish corresponding standard test methods, which can provide a technical basis for supervision. Conventional assay methods used in routine supervision include LC [1,2], GC [3], LC-MS/MS [4][5][6][7], and GC-MS/MS [8,9], which can accurately measure known cosmetic risk substances such as hormones [10,11], antibiotics [12,13], and other risky substances. However, conventional screening and detection methods need to be based on the information data of known risk substances.…”