Journal of AOAC International最新文献

{"title":"Correction to: Method for the Determination of 2'-Fucosyllactose (2'-FL), 3-Fucosyllactose (3-FL), 6'-Sialyllactose (6'-SL), 3'-Sialyllactose (3'-SL), Lacto-N-Tetraose (LNT), and Lacto-N-neoTetraose (LNnT) by High-Performance Anion-Exchange Chromatography With Pulsed Amperometric Detection (HPAEC-PAD): First Action 2022.04.","authors":"","doi":"10.1093/jaoacint/qsad119","DOIUrl":"10.1093/jaoacint/qsad119","url":null,"abstract":"","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"216"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influence of Organic and Inorganic Compounds of Various Metals on the Synthesis of Polysaccharides by the Medicinal Mushroom Trametes versicolor.","authors":"Kairat Mustafin, Zhanara Suleimenova, Zhanar Narmuratova, Nurlan Akhmetsadykov, Aigul Kalieva","doi":"10.1093/jaoacint/qsad113","DOIUrl":"10.1093/jaoacint/qsad113","url":null,"abstract":"<p><strong>Background: </strong>To date, basidiomycetes are considered to be promising objects of biotechnology, due to a number of biologically active compounds, such as polysaccharides and triterpenes. These compounds have a high therapeutic potential and demonstrate immunomodulatory, antiviral, and antifungal activities.</p><p><strong>Objective: </strong>The purpose of this study was to study the effect of various concentrations of metal citrates and sulphates on the content of exo- and endopolysaccharides of the fungus Trametes versicolor.</p><p><strong>Method: </strong>The mycelium was grown by deep cultivation on a semisyntheticglucose-peptone-yeast medium with different contents of zinc, copper, and manganese salts, after which the extraction and measurement of the concentration of polysaccharides were carried out.</p><p><strong>Results: </strong>The results obtained showed that copper citrate at a concentration of 4 mg/L had the greatest positive effect on biomass yield. The intensity of biomass growth on a nutrient medium with copper citrate increased by 80%. Zinc citrate increased the content of exopolysaccharides by 29% compared to the medium without metal salts. When manganese citrate was added to the medium, the productivity of synthesis decreased, but an increase in the growth rate of mycelium biomass was observed. Sulphates of these metals led to a decrease in the productivity of exopolysaccharide synthesis by 12% for zinc and 35% for manganese.</p><p><strong>Conclusions: </strong>The addition of both copper citrate and copper sulphate to the medium led to a decrease in the synthesis productivity by 66 and 24%, respectively. The introduction of both citrates and sulphates of these metals into the culture medium led to an increase in the percentage of endopolysaccharides in the mycelium of the fungus.</p><p><strong>Highlights: </strong>Copper citrate enhances Trametes versicolor biomass by 80%. Zinc citrate increases exopolysaccharide content by 29%. Copper sulphate optimizes endopolysaccharide production.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"112-119"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41158569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of Tilmicosin in Bovine, Swine, Chicken, and Turkey Tissues by Liquid Chromatography With Tandem Mass Spectrometry, Single-Laboratory Validation.","authors":"John Matt Rodewald, Thomas J Burnett, Sharon L Brunelle, Clive Ward, Mark R Coleman","doi":"10.1093/jaoacint/qsad117","DOIUrl":"10.1093/jaoacint/qsad117","url":null,"abstract":"<p><strong>Background: </strong>An LC-MS/MS method was developed for determination and confirmation of tilmicosin in bovine, swine, chicken, and turkey tissues (liver, kidney, muscle, and skin/fat) and bovine milk.</p><p><strong>Objective: </strong>The method was subjected to single-laboratory validation to establish method performance parameters.</p><p><strong>Method: </strong>Animal tissues and bovine milk were fortified at four concentrations ranging from 0.5 times the lowest maximum residue limit (MRL) or tolerance to 2 times the highest MRL or tolerance considering the Codex and EU MRLs and the US tolerances in the various tissues and milk studied. Incurred tissues were analyzed to verify the precision of the method.</p><p><strong>Results: </strong>The data demonstrated linearity of matrix-matched calibration curves using a weighted (1/×) regression. Recoveries varied from 83.3 to 107.1%. Repeatability precision (RSDr) ranged from 0.465 to 13.4% and intermediate precision (RSDi) ranged from 2.24 to 14.7% in fortified tissue. Repeatability of the method was verified in incurred tissues, ranging from 3.41 to 16.0%. The limits of detection and quantitation of the method are presented and vary by matrix. One confirmatory transition ion was examined across all matrixes and met US and EU criteria for mass spectrometry confirmation. The method was shown to be robust when small changes in method parameters were made, and stability of the analyte in fortified tissues, extracts, standard solutions, and matrix-matched standards was estimated.</p><p><strong>Conclusions: </strong>The data satisfy the requirements of the AOAC Stakeholder Panel for Veterinary Drug Residue Methods for single-laboratory validation studies and the U.S. Food and Drug Administration Center for Veterinary Medicine Guidance for Industry #208 (VICH GL49).</p><p><strong>Highlights: </strong>The LC-MS/MS method was demonstrated to be suitable for determination and confirmation of tilmicosin residues in bovine, swine, chicken, and turkey tissues and bovine milk based on Codex and EU MRLs and US tolerances.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"77-92"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41180736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimization of a Solid-Phase Extraction Coupled with a High-Performance Liquid Chromatography and Diode Array Ultraviolet Detection Method for Monitoring of Different Antibiotic Class Residues in Water Samples.","authors":"Rania A Mahmoud, Ghada M Hadad, Randa A Abdel Salam, Hatem I Mokhtar","doi":"10.1093/jaoacint/qsad111","DOIUrl":"10.1093/jaoacint/qsad111","url":null,"abstract":"<p><strong>Background: </strong>The increased use of cephalosporin antibiotics in the last few years as well as the detection of their residues in wastewater treatment plants and hospital wastewater poses a risk for infiltration of their residues into environmental water samples.</p><p><strong>Objective: </strong>A simplified, sensitive, and convenient solid-phase extraction (SPE) procedure coupled with either HPLC or fast HPLC methods with diode array detection was developed and validated to screen the residues of six different cephalosporin antibiotics: cefoperazone, cefipime, ceftazedime, ceftriaxone, cefdinir, and cefotaxime, along with amoxicillin, levofloxacin, and ciprofloxacin in water samples.</p><p><strong>Methods: </strong>An HPLC-diode array detector (HPLC-DAD) method and a fast HPLC method, based on a core-shell stationary phase, were developed for the fast screening of the antibiotic compounds. In addition, the SPE step was optimized to enable the extraction of the studied drugs with high accuracy of the recovered amounts of residues.</p><p><strong>Results: </strong>The method sensitivity was enhanced by the coupling of SPE with HPLC-DAD and fast HPLC to achieve low LODs; from 0.2 to 3.8 ng/mL and from 0.65 to 12.2 ng/mL, respectively. The developed methods were augmented by LC-MS/MS determination for confirmation of identity and quantity of any positively identified sample. The method was applied to the analysis of water samples collected from a rural site. In Addition, an example application of cleaning validation of cefotaxime-contaminated stainless-steel surfaces was provided.</p><p><strong>Conclusion: </strong>The method's simplicity and high sensitivity encourage its application in monitoring of antibiotic residues in different types of water samples such as environmental samples and samples from cleaning validation activities.</p><p><strong>Highlights: </strong>HPLC-DAD and fast HPLC methods were developed for separation of nine different antibiotics. The combination with the SPE procedure achieved low detection limits; from 0.2 to 3.8 ng/mL for SPE-HPLC-DAD and from 0.65 to 12.2 ng/mL for SPE-fast HPLC.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"52-60"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41175613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of Novel Quality Evaluation Methods to Differentiate Two Closely Related Species of Tinospora: A Rapid HPTLC- and HPLC-Based Assessment with MS/MS Characterization.","authors":"Aboli Girme, Ganesh Saste, Arun Kumar Balasubramaniam, Chetana Ghule, Vallabh Mulay, Lal Hingorani","doi":"10.1093/jaoacint/qsad110","DOIUrl":"10.1093/jaoacint/qsad110","url":null,"abstract":"<p><strong>Background: </strong>The sympatric occurrence of the species that often resulted in different gatherings of plant material, ambiguous history on traditional use, and taxonomic flux due to similarities within the Tinospora (Menispermaceae) taxa are some of the reasons that triggered the necessity to develop robust analytical methods for efficient QC, especially to recognize dry and powder forms.</p><p><strong>Objective: </strong>To develop novel HPTLC-based fingerprinting of two closely resembling Tinospora species followed by HPTLC-MS analysis and identification of compounds differentiating Tinospora crispa (TCP) and Tinospora cordifolia (TCR) and a rapid and quantitative assessment by HPLC with a photodiode array detector (HPLC-PDA) with MS/MS characterization of specific TCP and TCR analytical markers.</p><p><strong>Methods: </strong>An HPTLC-based method was developed using chloroform-toluene-methanol-formic acid (7 + 4 + 2 + 0.2, by volume). The TCP compounds could be distinguished and isolated using successive column chromatography with complete characterization. Further these used in the reverse phase (RP)-HPLC-PDA coupled with LC-ESI (electrospray ionization)-MS/MS to quantify and confirmation in TCP and TCR.</p><p><strong>Results: </strong>The fingerprinting showed distinct bands in TCP stems, confirmed as clerodane- furanoditerpenoids with indirect profiling by the HPTLC-MS technique. Systematic isolation confirmed these compounds as borapetosides B and E. Thus, the RP-HPLC-PDA method was developed for these borapetosides B and E, with tinosporide to differentiate these two species. The quantitation method was well validated with good linearity (r2 >0.99) with sensitive LOD (0.49-3.71 mcg/mL) and LOQ (1.48-11.23 mcg/mL) with recoveries of 92.34-96.19%.</p><p><strong>Conclusion: </strong>A novel, validated HPLC-PDA method showed good resolution and reliability (up to 1% adulteration) in quantification for targeted major analytical markers from TCP to differentiate TCR. Thus, HPTLC and HPLC-PDA-based techniques are helpful with MS/MS-based characterization to identify and quantify these analytical markers from TCP (borapetoside B and E) and TCR (tinosporide) in dry and powder form.</p><p><strong>Highlights: </strong>This article reports on the systemic use of HPTLC-MS for separating and identifying analytical markers in Tinospora species, distinguishing TCR and TCP with quantitative HPLC-PDA and MS/MS assessment.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"129-139"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41109418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"GC-MS Analysis of Primary Aromatic Amines Originated From Azo Dyes in Commercial Textile or Leather Products Using Helium Alternative Carrier Gases.","authors":"Maiko Tahara, Tsuyoshi Kawakami, Yoshiaki Ikarashi","doi":"10.1093/jaoacint/qsad116","DOIUrl":"10.1093/jaoacint/qsad116","url":null,"abstract":"<p><strong>Background: </strong>In recent years, due to the global shortage of helium gas, the development of gas chromatography (GC) analytical methods using alternatives to helium carrier gases is necessary.</p><p><strong>Objective: </strong>The objective of this study was to examine the applicability of hydrogen and nitrogen as alternative carrier gases using the test method for azo compounds in the Act on Control of Household Products Containing Harmful Substances of Japan.</p><p><strong>Method: </strong>The gas chromatograph mass spectrometer (GC-MS) analytical method using hydrogen and nitrogen as alternative carrier gases was compared with a method using helium for 26 primary aromatic amines (PAAs) originated from azo dyes.</p><p><strong>Results: </strong>When hydrogen and nitrogen were used as carrier gases under the same conditions used during analysis using helium (same column, gas flow rate, oven temperature conditions, etc.), sufficient peak separation of 26 PAAs was obtained. The sensitivities of the methods using helium and hydrogen were comparable, whereas the sensitivity was lower when nitrogen was used, with the detection limits ranging from 1/220 to 1/25. However, all carrier gases achieved quantification at concentrations below the standard value (30 μg/g) of the Act on Control of Household Products Containing Harmful Substances, and the results were in agreement with the standard value for the target product.</p><p><strong>Conclusions: </strong>Our results indicated that hydrogen or nitrogen can be used as alternative carrier gases to helium for GC-MS analysis of azo compounds producing specific aromatic amines.</p><p><strong>Highlights: </strong>Using hydrogen or nitrogen as an alternative carrier gas to helium, azo compounds could be quantified with excellent accuracy.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"61-68"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41125092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A New Cover for the Journal of AOAC INTERNATIONAL.","authors":"Xu-Liang Cao","doi":"10.1093/jaoacint/qsad121","DOIUrl":"10.1093/jaoacint/qsad121","url":null,"abstract":"","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41169420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Liquid Chromatography-Isotope Ratio Mass Spectrometry for Detection of Economically Motivated Adulteration of Maple Syrup.","authors":"Madhavi Mantha, Kevin M Kubachka, John R Urban, Jana L Brueggemeyer, Lisa A Kaine, Reagan A Patton","doi":"10.1093/jaoacint/qsad115","DOIUrl":"10.1093/jaoacint/qsad115","url":null,"abstract":"<p><strong>Background: </strong>Maple syrup is a sought-after commodity, and used as a condiment and a sweetener. Also, it is an active target of economically motivated adulteration (EMA), similar to other foods such as lemon juice and honey.</p><p><strong>Objective: </strong>This study is aimed to detect low cost sugar adulteration in maple syrup via an internal standard method using malic acid through solid-phase extraction (SPE) and LC with isotope ratio mass spectrometric detection (LC-IRMS).</p><p><strong>Methods: </strong>In this work, an optimized SPE sample preparation procedure was used for the isolation of organic acids from maple syrup. Using LC-IRMS, malic acid was separated from other organic acids and the δ13C value of malic acid was determined. Eleven maple syrup samples, domestic or imported from Canada, were evaluated for 13C/12C ratios (δ13C values) using combustion module-cavity ring down spectrometry (CM-CRDS) and compared to the δ13C values obtained from well-established elemental analyzer-isotope ratio mass spectrometry (EA-IRMS) methods. The δ13C values of isolated malic acid analyzed by SPE-LC-IRMS were used as internal standards and compared to the δ13C values of bulk maple syrup; difference (δ13Csugars - δ13Cmalic acid) values greater than 3.6‰ are indicative of low-cost sugar adulteration.</p><p><strong>Results: </strong>Overall, the results obtained from SPE-LC-IRMS provided a faster, novel analysis approach for determining low-cost sugar adulteration in maple syrup for regulatory purposes. This method also provided lower detectable limits of adulteration versus current literature reports using bulk analysis and comparable detection limits to Tremblay and co-workers who utilized an internal standard method.</p><p><strong>Conclusion: </strong>SPE-LC-IRMS is a robust method that can be used for detecting adulteration in maple syrup samples for regulatory purposes.</p><p><strong>Highlights: </strong>SPE-LC-IRMS is a faster, novel analysis approach for determining C4 adulteration in maple syrup with lower detection limits.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"69-76"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41160914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous Determination of Estradiol Cypionate and Medroxyprogesterone Acetate Hormones in Injectable Suspension by UV Spectrophotometry Based on Least-Squares Support Vector Machine and Fuzzy Inference System: Comparison with HPLC.","authors":"Maryam Valizadeh, Zahra Ameri Braki, Erfan Smiley","doi":"10.1093/jaoacint/qsad107","DOIUrl":"10.1093/jaoacint/qsad107","url":null,"abstract":"<p><strong>Background: </strong>The combination of estradiol cypionate (ECA) and medroxyprogesterone acetate (MPA) is used to prevent pregnancy in women. The analysis of the ECA and MPA combination reveals a challenge due to the strong overlap of the spectra of these compounds.</p><p><strong>Objective: </strong>Spectrophotometry techniques along with chemometrics methods are simple, fast, precise, and low-cost for the simultaneous determination of ECA and MPA in a combined pharmaceutical dosage form.</p><p><strong>Methods: </strong>Two developed approaches, the least-squares support vector machine (LSSVM) and fuzzy inference system (FIS), along with a spectrophotometric method were proposed to solve such a challenging overlap.</p><p><strong>Results: </strong>Based on the cross-validation method, the regularization parameter (γ) and width of the function (σ) in the LSSVM model were optimized and the root mean square error (RMSE) values were found to be 0.3957 and 0.2839 for ECA and MDA, respectively. The mean recovery values were 99.87 and 99.63% for ECA and MDA, respectively. The FIS coupled with principal component analysis (PCA) showed mean recovery percentages equal to 99.05 and 99.50% for ECA and MDA, respectively. Also, the RMSE of both components was lower than 0.3.</p><p><strong>Conclusion: </strong>The analysis results of a real sample (injection suspension) using the proposed methods were compared with HPLC by a one-way analysis of variance (ANOVA) test, and no significant differences were found in the results.</p><p><strong>Highlights: </strong>Intelligent methods were proposed for the simultaneous determination of ECA and MPA. The least-squares support vector machine and fuzzy inference system along with spectrophotometry were used. HPLC as a reference method was performed and compared with chemometrics methods. The benefits of the proposed approaches are that they are rapid, simple, low-cost, and accurate.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"196-204"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41169421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developed and Validated for the Estimation of Tapinarof in Topical Formulation and Active Pharmaceutical Ingredients.","authors":"Raghunatha Reddy Chavva, Nageswara Reddy Gosu","doi":"10.1093/jaoacint/qsad124","DOIUrl":"10.1093/jaoacint/qsad124","url":null,"abstract":"<p><strong>Background: </strong>Its broad applicability and capacity to separate numerous components in a single chromatographic run led to the initial recognition of reversed-phase (RP)-HPLC as an analytical technique.</p><p><strong>Objective: </strong>The objective of this study was to create a straightforward and reliable method for accurately and precisely measuring the amount of tapinarof in both the topical formulation and the active pharmaceutical ingredient. Additionally, a robust HPLC assay was developed specifically for analyzing the topical formulation.</p><p><strong>Methods: </strong>In this study, chromatographic analysis was conducted using a Kromosil C18 column with dimensions of 250 × 4.6 mm and a particle size of 5 microns. The mobile phase consisted of a phosphate buffer and methanol in a ratio of 100:900 (v/v). The flow rate was set at 1.0 mL/min, with an injection volume of 10 µL and a run time of 6 min using isocratic elution. UV detection was performed at a wavelength of 313 nm, and the temperature was maintained at 30°C. The analysis showed well-separated peaks with a high number of theoretical plates, a low tailing factor, and consistent retention time. Validation of the method was conducted, and all validation parameters were found to be within the acceptable limits.</p><p><strong>Results: </strong>A method that is simple, accurate, and precise has been developed to estimate the amount of tapinarof in a topical formulation and active pharmaceutical ingredient. The optimized method involved the use of a column temperature set at 30°C, 90% methanol as the mobile phase, and a flow rate of 1.0 mL/min. The retention time for tapinarof was determined to be 2.88 min. The method exhibited linearity in the concentration range of 5 to 30 µg/mL (with an R2 value greater than 0.999) for tapinarof.</p><p><strong>Conclusion: </strong>The topical formulated cream and active pharmaceutical ingredient showed more than 90% dissolution within 5 min. The method developed in this study utilized photo diode array (PDA) for peak integrity and purity confirmation, making it suitable for the quantification of tapinarof in both topical formulations and active pharmaceutical ingredients.</p><p><strong>Highlights: </strong>The method was validated and can be recommended for routine analysis in QC laboratories.</p>","PeriodicalId":94064,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"46-51"},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41224066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}