Journal of AOAC International

BACKGROUND: The presentation of rhinitis has recently drawn increasing attention in recent years due to the possibility of overlap or confusion between allergic rhinitis symptoms and those of pandemic COVID-19. Azelastine hydrochloride (AZH) and mometasone furoate (MOF) are two of the most efficient combinations for enhancing the symptoms of seasonal allergic rhinitis. OBJECTIVE: This work concerns with applying and validating different accurate and simple spectrophotometric approaches for simultaneous quantification of the binary mixture of AZH and MOF in raw material, laboratory prepared mixtures, and pharmaceutical preparation...

BACKGROUND: Camptothecin is a potent anti-cancer drug used for the treatment of various cancers. OBJECTIVE: The goal of this research investigation was to develop and validate a new stability indicating HPLC technique for the quantitative assessment of camptothecin in in-house developed mesoporous silica nanoparticles, a novel nanoformulation matrix for the treatment of cancer. METHOD: The Waters Inertsil® HPLC column (C18) was used for the chromatographic separation, with a flow rate of 1 mL/min, a column oven temperature of 40 °C, an injection volume of 10 µL, a detection wavelength of 216 nm, and a 10 min runtime overall...

BACKGROUND: For pathogen detection in food, there are occasions where samples cannot be processed immediately after selective enrichment or need to be reexamined days/weeks later for confirmation or retest. OBJECTIVE: This study aimed to investigate the effect of different prolonged period of storage of selective enrichments of food at 4 ± 2 °C and room temperature (20-22 °C) on the detection and isolation of Salmonella. METHODS: This study included two experiments involving 34 types of foods to compare the effect of 4 ± 2 °C and room temperature storage on the detection of Salmonella in 204 selective enrichments [Rappaport-Vassiliadis (RV) and Tetrathionate (TT) broths] during a 42-day storage (Experiment I); and to monitor the survival of Salmonella in 300 selective enrichments (RV and TT) with different pre-enrichment broths [Lactose broth (LB) or Buffered peptone water broth (BPW)], stored at 4 °C for 60 days (Experiment II)...

BACKGROUND: Myrcene and cymene, aromatic monoterpenes found in plants and essential oils, possess distinctive aromatic qualities. However, their volatility and limited solubility pose challenges in precise handling and formulation. Meanwhile, nanoemulsions emerge as promising drug delivery systems, improving the bioavailability and stability of these active ingredients. OBJECTIVE: This article aimed to develop an HPLC method for the quantification of two monoterpenoids, p-cymene, and myrcene, in nanoemulsions...

BACKGROUND: Emergence and dissemination of antibiotic resistance is one of the major risks associated with the rampant usage of antibiotics in food-producing animals including aquaculture. OBJECTIVE: To determine Epidemiological Cut-OFF (ECOFF) values of heterotrophic bacterial populations from shrimp culture environment against five different antibiotics. METHODS: In this present study, 2304 heterotrophic bacteria were isolated from Penaeus vannamei culture environment in 12 different locations of Andhra Pradesh, which is the aquaculture hub of India...

BACKGROUND: Analytical quality by design (AQbD) affords a systematic scaffolding to triumph a continuously validated, robust assay as well as life cycle management. The resuscitative repurposed drug Favipiravir, an oral drug approved for reemerging pandemic influenza in Japan - 2014 used for the treatment of life threatening pathogens such as Ebola, Lassa virus and currently COVID-19. Favipiravir is gaining a great deal of medical importance due to its pharmaceutical applications. OBJECTIVE: To develop and validate a risk based stability indicating RP HPLC method employing AQbD approach using Central Composite Design (Design Expert Software 13...

BACKGROUND: The Eco-friendly analytical technique was developed for intention of preserving the environment by using green chemistry principles. Pemetrexed is folate analogue indicated for treatment of advanced lung cancer. OBJECTIVE: Development of Green Stability indicating HPLC method for quantification of Pemetrexed (Ditromethamine) impurities in API and parenteral dosage form. METHOD: Chromatographic separation was achieved by using Zorbax SB C18 column (150 mm x 4...

Since 2019 the world is in a combat with the highly contagious disease COVID-19 that is caused by the rapid transmission of SARS-CoV-2 virus (severe acute respiratory syndrome- coronavirus-2). Detection of this disease in an early stage helps to control its spread and management. To combat this epidemic with one-time effective medication improved quick analytical procedures must be developed and validated. The requirement of accurate and precise analytical methods for the diagnosis of the virus and antibodies in infected patients has been a matter of concern...

BACKGROUND: Qianlie Shule capsules is a classical Chinese medicine compound preparation that is frequently used in therapeutic settings to alleviate astringent pain in the urethra, prostatic hypertrophy, and chronic prostatitis or urinary frequency. However, a comprehensive analysis of the chemical composition of Qianlie Shule capsules has not been reported. OBJECTIVE: To establish a quick and effective analytical method based on hybrid quadrupole-orbitrap mass spectrometry ultra-high-performance liquid chromatography (UPLC-Q-Orbitrap-MS/MS) for the identification and characterisation of chemical components in Qianlie Shule capsules...

BACKGROUND: Acrylamide (AA) is a process contaminant naturally formed during the cooking of starchy food at high temperatures. Considering existing risks of misquantification inherent to the analysis of AA, an AOAC initiative raised the need for a consensus standard to determine AA in a broad variety of food. OBJECTIVE: A quantitative LC-MS/MS method for AA determination in food was validated in a single laboratory study. Targeted performance requirements in terms of target matrices, limit of quantification, recovery and precision were as defined per SMPR 2022...

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BACKGROUND: SARS-CoV-2 is a threat for humanity. Both the Spike (S) protein and its receptor binding domain (sRBD) are extensively used for the rapid detection. Although real time reverse transcription polymerase chain reaction (rRT-PCR) is mostly used method for the molecular detection of SARS-CoV-2, rapid assays for antigenic detection is always needed. Lateral flow assays (LFAs) are the most commonly used tests for this purpose and aptamers having stability and long shelf life are used as capture reagents...

BACKGROUND: Human milk oligosaccharides (HMOs) are important components of breast milk and may be responsible for some of the benefits of breastfeeding, including resistance to infections and the development of a healthy gut microbiota. Selected HMOs are now available for addition to infant formula, and suitable methods to control the dosing rate are needed. OBJECTIVE: To develop and validate a suitable method for the analysis of HMOs in infant formula. METHOD: A method was developed for the determination of seven human milk oligosaccharides (2'-fucosyllactose, 3-fucosyllactose, 3'-sialyllactose, 6'-sialyllactose (6'SL), 2',3-difucosyllactose, lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT)) in infant formula and adult nutritionals...

BACKGROUND: Holding times for raw materials are relevant, since they enable us to understand the allowable time that a raw material can be kept under ideal storage conditions before the start of the manufacturing process without its quality attributes being affected. The quantification of water activity can be used as an indicator of the microbiological, physicochemical, and organoleptic stability of a specimen, since low water activity retards autohydrolysis and microbiological growth...

BACKGROUND: When detecting Salmonella spp. in food samples, unlike with culture-based procedures where there are solid standards, PCR techniques are generally dominated by commercial solutions, often backed by the conformity of reference organizations, and based on rigorous validation studies. The few independent standards that exist are not subject to revision and improvement to the same extent as the manufacturer's methods. Moreover, since commercial networks do not promote them, they are less implemented in everyday practice...

BACKGROUND: A method for sugar profile analysis granted First Action 2018.16 was subjected to a multi-laboratory study. OBJECTIVE: Perform a multi-laboratory study with this method to determine the performance parameters of repeatability and reproducibility against the AOAC Standard Method Performance Requirements (AOAC SMPR 2018.001) for Final Action status. METHODS: Eleven laboratories from three different countries participated in the study...

BACKGROUND: Botanical reference materials (BRMs) generally account for the species, cultivar, and year and location of harvest that result in variability in the chemical composition that may lead to statistically significant differences using chemometric methods. OBJECTIVE: To Compare the chemical composition of 5 species of Actaea root BRMs, 4 herbal sources of A. racemosa root BRMs, and A. racemosa BRMS, and commercial roots and supplements using chemometric methods and selected pre-processing approaches...

BACKROUND: Oxitropium Bromide (OB) and Formoterol Fumarate Dihydrate (FFD) are inhaler molecules that are widely used in the treatment of chronic lung diseases. OBJECTIVE: The goal of this work was to create a reversed phase-ultra performance liquid chromatography (RP-UPLC) technique for assay and identification of OB and FFD, as well as identification and estimate of its associated compounds in pressurised metered dose inhaler product (pMDI). METHOD: Separation of oxitropium and formoterol peaks were enhanced on C18 (50 x 2...

BACKGROUND: There is an increasing interest in the use of a combination of trans-resveratrol and vitamin E in dietary supplements. Determination of the content of both components is essential for confirmation of the quality of the product. OBJECTIVE: To establish the applicability and ensure the greenness of the previously developed high-throughput HPLC/UV method for the simultaneous determination of trans-resveratrol and alpha-tocopherol acetate (vitamin E) in dietary supplements...

BACKGROUND: Neonicotinoids are used for the phystosanitary treatment of Mentha Spicata.L crops, and this practice requires precise control of these harmful substances at very low concentrations. OBJECTIVE: The objective of this study is to apply an approach allowing simultaneously validation and evaluation of measurement uncertainty based on total error methodology, in order to accurately quantify the presence of two neonicotinoids in Mentha Spicata.L utilizing a QuEChERS-LC-MS/MS methodology...