Industrial Chemistry
Open Access

A new infectious disease, Coronavirus Disease-2019 (COVID-19), was discovered following an outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Wuhan, China. Since then, COVID-19 has developed into an unprecedented global pandemic that has posed serious threats to public health. As a result, it was still necessary to take preventative measures to stop the spread of infection. Because of this, public health agencies all over the world advised hand washing as one strategy for reducing the transmission of COVID-19 [1-3].

It has been demonstrated that practicing good hand hygiene can lower overall infection rates, reduce the spread of antimicrobialresistant organisms, and prevent outbreaks in healthcare facilities. Consequently, the US Centers for Disease Control and Prevention updated their hand hygiene guidelines for healthcare facilities in 2002 to recommend that healthcare workers wash their hands with alcohol-based hand rubs rather than soap and water when caring for patients. After that, a hand hygiene guide called the Alcohol-Based Hand Sanitizer (ABHS) Guide was published by the World Health Organization (WHO).

A study that was carried out by Swiss and German researchers was published in the journal Emerging Infectious Diseases. With a virus reduction factor of 3.8 and 5.9, respectively, they discovered that the WHO-recommended original and modified ABHS formulations both effectively eradicated SARS-CoV-2. At a concentration of more than 30% v/v6, ethanol and isopropyl alcohol (IPA) were also found to be effective in inactivating the virus in 30 seconds. The WHO recommends two ABHS formulations that are currently widely accepted worldwide and only differ in their alcohol content. In addition to other components like glycerol, hydrogen peroxide, and sterile or distilled water, Formulation 1 contains 80% ethanol by volume and Formulation 2 contains 75% IPA by volume [4]. There should be no additional dynamic or idle fixings added because doing so could compromise the product's strength and quality. Microorganisms are killed most effectively by ABHS containing 60 to 95% v/v alcohol if at least 2.4 mL of hand sanitizer is used for 25 to 30 seconds .

In 20098, consumers' fear of contracting the novel influenza A (H1N1) swine flu and recommendations for ABHS from healthcare professionals led to the first significant increase in sales of hand sanitizer. Again, during the COVID-19 pandemic, ABHS proved to be an important tool for reducing skin-to-skin SARS-CoV-2 transmissions. Due to a sudden rise in demand, there were shortages of hand sanitizers in the early stages of the COVID-19 outbreak. Hand sanitizer sales increased by 471 percent in the first week of March 2020 compared to the previous year, according to Nielsen market research in the United States . Numerous regulatory agencies have relaxed the requirements of their regulations as a result of the severe shortage of hand sanitizers [5].

In recognition of the opportunity and in response to customer demands, cosmetic and skincare companies have expanded their product lines to include ABHS10. Despite the fact that these new manufacturers frequently possess the technology and components required to manufacture ABHS, there are concerns that they are unaware of their regulatory obligations. Even though health regulators have told the industry to make ABHS when there is a public health emergency, some manufacturers may have used internal formulations that haven't been tested or given permission to use. These include finding low levels of active ingredients and dangerous quantities of impurities like methanol. Additionally, the claims made on the labels of some of these products were either incorrect, unsupported, or deceptive. Unsafe or substandard ABHS products that, when used, could be harmful to human health and the environment were reported to health regulatory authorities.

In Malaysia, ABHSs are categorized as cosmetics or generic products based on their intended use. The National Pharmaceutical Regulatory Agency (NPRA) has received notification applications to import, manufacture, or market ABHS as cosmetics since the COVID-19 pandemic. Restorative items should generally be advised, manufactured in a manner that satisfies the requirements of Good Assembling Practice for restorative items or an equivalent, and adhere to the requirements outlined in the Rules for Control of Corrective Items in Malaysia. In addition, the NPRA has established a specific requirement for ABHS, stating that the active ingredient must contain at least 60% alcohol and that the manufacturer can only make claims regarding the product's antibacterial and hygiene properties . The NPRA, Malaysia's regulatory body in charge of cosmetic product compliance and quality control, reported in this paper the development of a GC– MS-based analytical method to simultaneously identify and quantify ethanol, IPA, and methanol in ABHSs. The method was meticulously optimized and validated to ensure robust and dependable performance for the purpose of determining alcohols and other impurities in liquid and gel ABHS products [6].

Materials and Method

It is essential to accurately measure the concentration of ethanol, isopropyl alcohol, and methanol in order to guarantee the effectiveness and safety of alcohol-based hand sanitizers. The instruments and analytical techniques commonly used to analyze these compounds in hand sanitizers are discussed in this section.

Materials and procedures A GC system coupled to a quadrupole mass spectrometer (GC–MS TQ8040, Shimadzu Corporation, Japan) was used for the analysis. A BP-624 GC capillary column (part number:) was used to separate the compounds. 054840, Trajan, Australia) with dimensions of 30 m (length) and a film thickness of 1.4 m (internal diameter) less than 0.25 mm. At a flow rate of 1 mL/min, helium served as the carrier gas. The GC oven temperature was programmed with an initial temperature of 60 °C and a hold time of 3 minutes, followed by increases to 90 °C at 30 °C/min and 230 °C at 55 °C/min. The split injection mode was chosen with an injection volume of 0.2 L. The total run time was 9.55 minutes, and the final temperature was held for 3 minutes. The temperatures of the injection and interface were set at 230 °C.

GC: Gas chromatography

For the analysis of volatile compounds like ethanol, isopropyl alcohol, and methanol, gas chromatography is widely used. The GC analysis of hand sanitizers involves the following steps:

a. How to Prepare a Sample:

To bring the sample of hand sanitizer within the instrument's concentration range, it is typically diluted with a suitable solvent. The volatile compounds can also be extracted from the sample using solidphase microextraction (SPME) methods.

b. Separation and Injection:

A suitable column-equipped gas chromatograph is injected with the prepared sample. The volatile compounds are separated according to their interactions with the stationary phase and retention times.

c. Finding:

A suitable detector, such as a mass spectrometer or flame ionization detector (FID), is used to detect the separated compounds. Each compound's concentration is proportional to the signal produced by the detector [7-10].

Liquid chromatography with high performance (HPLC):

Another widely used method for analyzing alcohol-based hand sanitizers is HPLC. Ethanol, isopropyl alcohol, and methanol can all be determined using HPLC, which has advantages for non-volatile compound analysis. The following steps are involved in the analysis:

a. How to prepare a sample:

To bring the sample of hand sanitizer within the instrument's concentration range, it is typically diluted with a suitable solvent. Analytes can be extracted from a sample using solid-phase extraction (SPE) methods.

b. Separation and injection:

An HPLC system is used to inject the prepared sample into a stationary phase column that is appropriate. Based on how the compounds of interest interact with the mobile and stationary phases, they are separated.

c. Identification

A suitable detector, such as a UV-Visible or refractive index detector, is used to detect the separated compounds. Each compound's concentration is proportional to the signal produced by the detector.

Infrared spectroscopy with a Fourier transform (FTIR):

The qualitative and quantitative analysis of ethanol, isopropyl alcohol, and methanol in hand sanitizers can be done with FTIR spectroscopy. The procedure consists of the following steps:

• How to prepare sample

The sample of hand sanitizer is typically prepared as a thin film or mixed with an appropriate attenuated total reflection (ATR) crystal so that it can interact with infrared radiation.

• Dimensions

The sample's absorption spectrum is recorded after it is subjected to infrared light. Alcohol compounds can be identified and quantified thanks to the spectrum's information about the sample's functional groups.

Conclusion

A GC–MS-based method was developed, improved, and validated for the purpose of assessing the quality, safety, and efficacy of ABHS products. The active ingredient in ABHS, ethanol or IPA, can be identified and quantified using this method. Additionally, it can be used to simultaneously identify and quantify methanol, an undesirable impurity in hand sanitizers. To demonstrate the method's applicability, 69 liquid and gel ABHS samples from the Malaysian market were utilized. The methods that have been discussed here would be helpful in preventing the public from being harmed by ABHS products that are unsafe or not up to standard. Consequently, a regulatory body like the NPRA must ensure that ABHSs contain the required alcohol percentage and do not contain any potentially harmful impurities like methanol. Gas chromatography, high-performance liquid chromatography, and Fourier transform infrared spectroscopy are the most frequently used techniques for analyzing ethanol, isopropyl alcohol, and methanol in alcohol-based hand sanitizers. These instruments and the appropriate methods of sample preparation that provide accurate and reliable alcohol concentration measurements guarantee the safety and efficacy of hand sanitizers.

1. Croissant J, Zink J I (2012) Nanovalve-Controlled Cargo Release Activated by Plasmonic Heating. J Am Chem Soc 134:7628–7631.

Indexed at, Google Scholar, Crossref

2. Zink, Jeffrey (2014) Photo-redox activated drug delivery systems operating under two photon excitation in the near-IR. Nanoscale 6:4652– 4658.

Indexed at, Google Scholar

3. Langer, Robert (2010) Nanotechnology in Drug Delivery and Tissue Engineering: From Discovery to Applications. Nano Lett 10:3223–3230.

Indexed at, Google Scholar, Crossref

4. Abrigo M, Arthur M, Kingshott P (2014) Electrospun nanofibers as dressings for chronic wound care :advances, challenges, and future prospects. Macromolecular Bioscience 14:772-792.

Indexed at, Google Scholar, Crossref

5. Xiang DX, Chen Q, Pang L, Zheng Cl (2011) Inhibitory effects of silver nanoparticles on H1N1 influenza A virus in vitro. J Virol Methods 7: 137–142.

Indexed at, Google Scholar, Crossref

6. Harris N, Ford MJ, Cortie MB (2006) Optimization of plasmonic heating by gold nanospheres and nano shells . Phys Chem B110:10701-10707.

Indexed at, Google Scholar, Crossref

7. Baffou G, Quidant R, Girard C (2009) Heat generation in plasmonic nanostructures: Influence of morphology.Appl Phys Lett94:153109.

Indexed at, Google Scholar, Crossref

8. Seethapathy S, Gorecki T (2012) Applications of polydimethylsiloxane in analytical chemistry: A review.Anal Chim Acta750:48-62.

Indexed at, Google Scholar, Crossref

9. Al-Enizi AM, Zagho MM, Elzatahry AA (2018)Polymer-based electrospun nanofibers for biomedical applications.J Nanomater 8: 259.

Indexed at, Google Scholar, Crossref

10. Ginger DS, Zhang H, Mirkin CA (2004) The evolution of dip pen nanolithography.Angew Chem Int Ed 43:30-45.

Indexed at, Google Scholar, Crossref