Determination of ethanol, isopropyl alcohol and methanol in alcohol-based hand sanitiser to ensure product quality, safety and efficacy.

The Coronavirus Disease-2019 (COVID-19) outbreak is an unprecedented global pandemic, sparking grave public health emergencies. One of the measures to reduce COVID-19 transmissions recommended by the World Health Organization is hand hygiene, i.e., washing hands with soap and water or disinfecting them using an alcohol-based hand sanitiser (ABHS). Unfortunately, competing ABHSs with unknown quality, safety, and efficacy thrived, posing yet another risk to consumers. This study aims to develop, optimise, and validate a gas chromatography-mass spectrometry (GC-MS)-based analytical method to simultaneously identify and quantify ethanol or isopropyl alcohol as the active ingredient in ABHS, with simultaneous determination of methanol as an impurity. The GC-MS was operated in Electron Ionisation mode, and Selected Ion Monitoring was chosen as the data acquisition method for quantitation. The analytical method was validated for liquid and gel ABHSs, covering the specificity, linearity and range, accuracy, and precisions, including the limit of detection and the limit of quantitation. The specificity of each target analyte was established using the optimised chromatographic separation with unique quantifier and qualifier ions. The linearity was ascertained with a coefficient of determination (r2) of > 0.9994 over the corresponding specification range. Respectively, the accuracy and precisions were satisfactory within 98.99 to 101.09% and < 3.04% of the relative standard deviation. The method was successfully applied to 69 ABHS samples, where 14 contained insufficient amounts of the active ingredient. Alarmingly, four samples comprised a high amount of methanol ranging from 5.3 to 19.4% with respect to the active alcohol percentage, which may pose significant short- and long-term health issues, leading to life-threatening crises for consumers. The method established would benefit in protecting the public against the potential harm due to substandard or unsafe ABHS products, primarily due to the presence of hazardous impurities such as methanol.

Phosphodiesterase-5 inhibitors and their analogues as adulterants of herbal and food products: analysis of the Malaysian market, 2014-16.

Adulteration of herbal health supplements with phosphodiesterase-5 (PDE-5) inhibitors and their analogues is becoming a worldwide problem. The aim of this study was to investigate herbal and food products sold in the Malaysian market for the presence of these adulterants. Sixty-two products that claim to enhance men's sexual health were sampled between April 2014 and April 2016. These products included unregistered products seized by the Pharmacy Enforcement Division of the Ministry of Health (n = 39), products sent to the National Pharmaceutical Regulatory Agency for pre-registration testing (n = 9) and products investigated under the post-registration market surveillance programme (n = 14). The products were tested against an in-house spectral library consisting of 61 PDE-5 inhibitors and analogues using a validated liquid chromatography-mass spectrometry ion-trap-time-of-flight (LC-MS IT-TOF) method. Thirty-two (82%) of the unregistered products and two (14%) of the registered products were found to be adulterated with at least one PDE-5 inhibitor or analogue, while none of the pre-registration products contained adulterants. A total of 16 different adulterants were detected and 36% of the adulterated products contained a mixture of two or more adulterants. This study has demonstrated that the adulteration of unregistered herbal products in the Malaysian market is an alarming issue that needs to be urgently addressed by the relevant authorities.