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Journal articles on the topic 'LC-MS/MS method validation'

Author: Grafiati

Published: 4 June 2021

Last updated: 14 February 2022

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1

Wang, Meng, Wen Jia Zhou, Quan Ying Zhang, and Ming Huang. "Development and Validation of a LC–MS/MS Method." Advanced Materials Research 722 (July 2013): 255–59. http://dx.doi.org/10.4028/www.scientific.net/amr.722.255.

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A simple, sensitive, selective, rapid, reproducible and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the identification and quantification of paroxetine (PAX) in human plasma,. Chromatographic separation was performed on XTerra RP18 (5 μm, 150 mm × 4.6 mm i.d.) column with mobile phase composed of 10 mM ammonium acetate containing 0.2% formic acid: methanol (30:70, v/v) at flow rate of 0.9 mL min-1. PAX and CZP were detected with proton adducts at m/z (amu) 330.1 192.1 and 327.2 270.1, in multiple reaction monitoring (MRM) positive mode. The method was validated over the concentration range of 0.05 - 30 ng mL-1. The lower limit of quantification (LLOQ) was 0.05 ng mL-1. The inter-run and intra-run precision was within 2.1-11.8% and 2.2-5.8%, respectively

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Kim, Yunjeong, Song-Hee Han, Ji-Young Jeon, Min-Ho Hwang, Yong-Jin Im, Sun Young Lee, Soo-Wan Chae, and Min-Gul Kim. "Validation of LC-MS/MS method for determination of ginsenoside Rg1 in human plasma." Analytical Science and Technology 26, no. 4 (August 25, 2013): 221–27. http://dx.doi.org/10.5806/ast.2013.26.4.221.

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3

Iram, Farah, Huma Iram, Mohd Arif, A. A. Siddiqui, and Asif Husain. "Bioanalytical Method Development and Validation by Hyphenated Technique (LC-MS/MS)." Journal of Pharmaceutical and Medicinal Chemistry 2, no. 1 (2016): 11–26. http://dx.doi.org/10.21088/jpmc.2395.6615.2116.2.

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4

Yang, Lufang, Gordon Ball, and Gordon Hoag. "Validation of a LC–MS/MS method for urinary free cortisol." Clinical Biochemistry 48, no. 15 (October 2015): 1014. http://dx.doi.org/10.1016/j.clinbiochem.2015.07.059.

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5

Kwak, Eun-Young. "Method validation of heterocyclic amines in fish with LC-MS/MS." Drug Metabolism and Pharmacokinetics 32, no. 1 (January 2017): S29. http://dx.doi.org/10.1016/j.dmpk.2016.10.134.

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Kim, Yun-Jeong, Song-Hee Han, Ji-Young Jeon, Min-Ho Hwang, Yong-Jin Im, Soo-Wan Chae, and Min-Gul Kim. "Validation of LC-MS/MS method for determination of ertapenem in human plasma and urine." Analytical Science and Technology 25, no. 1 (February 25, 2012): 19–24. http://dx.doi.org/10.5806/ast.2012.25.1.019.

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7

Erdoğar, Nazlı, Tuba Reçber, Alper B. İskit, Erem Bilensoy, Sedef Kır, and Emirhan Nemutlu. "Determination and validation of aprepitant in rat plasma using LC−MS/MS." Bioanalysis 13, no. 5 (March 2021): 363–72. http://dx.doi.org/10.4155/bio-2020-0293.

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Aim: The assessment of efficacy should be paralleled with extensive pharmacokinetic parameters, and a valid bioanalytical method is a pre-condition for accurate plasma concentration. Materials & methods: A simple, specific, rapid and sensitive LC−MS/MS method has been developed for quantitative analysis of aprepitant in rat plasma. A C18 column was used as stationary phase and the mobile phase consisted of a mixture of formic acid in water and formic acid in acetonitrile. Quantification was performed using multiple reaction monitoring mode. Results: The selectivity, linearity, accuracy, precision, robustness and ruggedness of the method were evaluated in accordance with bioanalytical method validation guideline of ICH and all results were within the acceptable range. Conclusion: The validated LC−MS/MS method was found to be useful for the quantitative analysis of aprepitant in rat plasma samples.

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L. Pithiya, Gaurang, Nilesh K. Patel, Ashok B. Patel, Amit J. Vyas, and Ajay Patel. "A Review on Bioanalytical Method Development and Validation by LC-MS/MS." Journal of Pharmaceutical and Medicinal Chemistry 2, no. 1 (2016): 95–101. http://dx.doi.org/10.21088/jpmc.2395.6615.2116.9.

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9

Duggan, Jeffrey X., Faye Vazvaei, and Rand Jenkins. "Bioanalytical method validation considerations for LC–MS/MS assays of therapeutic proteins." Bioanalysis 7, no. 11 (June 2015): 1389–95. http://dx.doi.org/10.4155/bio.15.69.

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Meyer, Lyndsey F., and Dhaval K. Shah. "Development and validation of an LC-MS/MS method for tyrphostin A9." Journal of Pharmaceutical Analysis 9, no. 3 (June 2019): 163–69. http://dx.doi.org/10.1016/j.jpha.2019.03.003.

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11

Han, Song-Hee, Yunjeong Kim, Ji-Young Jeon, Minho Hwang, Yong-Jin Im, Sun Young Lee, Soo-Wan Chae, and Min-Gul Kim. "Validation of the LC-MS/MS Method for Ginsenoside Rb1 Analysis in Human Plasma." Journal of the Korean Society of Food Science and Nutrition 41, no. 12 (December 31, 2012): 1753–57. http://dx.doi.org/10.3746/jkfn.2012.41.12.1753.

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12

Dmitrovic, Jasna, and David A. Durden. "Analysis of Fumagillin in Honey by LC-MS/MS." Journal of AOAC INTERNATIONAL 96, no. 3 (May 1, 2013): 687–95. http://dx.doi.org/10.5740/jaoacint.12-174.

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Abstract An LC/MS/MS method has been optimized and validated for the quantification and confirmation of fumagillin in honey. Fumagillin is isolated and concentrated by RP polymeric SPE. Final extracts are analyzed using electrospray ionization LC/MS/MS in positive mode with a formic acid and ammonium formate–acetonitrile mobile phase. Method uncertainty was determined using two analytical systems from different manufacturers. The validation of this LC/MS/MS method for the detection of fumagillin demonstrated overall recovery of 99.3%, precision of 5.9%, expanded uncertainty of 13.2%, and LOD of 0.368 μg/kg using an Agilent 6410 triple quadrupole system. Robustness testing showed that the method is robust against small changes in the method parameters. The method has been successfully applied to test 30 honey samples received as part of the Canadian Food Inspection Agency inspection program for the presence of fumagillin. It also was externally evaluated through proficiency testing and found to be fit-for-purpose.

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Vazvaei, Faye, and Jeffrey X. Duggan. "Validation of LC–MS/MS bioanalytical methods for protein therapeutics." Bioanalysis 6, no. 13 (July 2014): 1739–42. http://dx.doi.org/10.4155/bio.14.125.

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Villar-González, Adriano, María Luisa Rodríguez-Velasco, and Ana Gagoo-Martínez. "Determination of Lipophilic Toxins by LC/MS/MS: Single-Laboratory Validation." Journal of AOAC INTERNATIONAL 94, no. 3 (May 1, 2011): 909–22. http://dx.doi.org/10.1093/jaoac/94.3.909.

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Abstract An LC/MS/MS method has been developed, assessed, and intralaboratory-validated for the analysis of the lipophilic toxins currently regulated by European Union legislation: okadaic acid (OA) and dinophysistoxins 1 and 2, including their ester forms; azaspiracids 1, 2, and 3; pectenotoxins 1 and 2; yessotoxin (YTX), and the analogs 45 OH-YTX, Homo YTX, and 45 OH-Homo YTX; as well as for the analysis of 13-desmetil-spirolide C. The method consists of duplicate sample extraction with methanol and direct analysis of the crude extract without further cleanup or concentration. Ester forms of OA and dinophysistoxins are detected as the parent ions after alkaline hydrolysis of the extract. The validation process of this method was performed using both fortified and naturally contaminated samples, and experiments were designed according to International Organization for Standardization, International Union of Pure and Applied Chemistry, and AOAC guidelines. With the exception of YTX in fortified samples, RSDr below 15% and RSDR were below 25%. Recovery values were between 77 and 95%, and LOQs were below 60 μg/kg. These data together with validation experiments for recovery, selectivity, robustness, traceability, and linearity, as well as uncertainty calculations, are presented in this paper.

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Kahl, Kristin W., Joshua Z. Seither, and Lisa J. Reidy. "LC-MS-MS vs ELISA: Validation of a Comprehensive Urine Toxicology Screen by LC-MS-MS and a Comparison of 100 Forensic Specimens." Journal of Analytical Toxicology 43, no. 9 (August 19, 2019): 734–45. http://dx.doi.org/10.1093/jat/bkz066.

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Abstract Toxicology laboratories commonly employ immunoassay methodologies to perform an initial drug screen on urine specimens to direct confirmatory testing. Due to limitations of immunoassay testing and the need to screen for a broader range of drugs with lower limits of detection at a lower cost, mass spectrometry screening techniques have gained favor in the toxicology field. A liquid chromatography–tandem mass spectrometry (LC-MS-MS) urine screening panel was developed and validated for 52 drugs and metabolites. A simple dilute-and-shoot with enzymatic hydrolysis technique was utilized to prepare the urine specimens for analysis. Limit of detection, interference, ionization suppression/enhancement, carryover and stability of processed specimens were assessed during validation. To evaluate the toxicological results obtained from utilizing the LC-MS-MS in comparison with the laboratory’s current enzyme-linked immunosorbent assay (ELISA) panel, 100 authentic urine specimens from suspected driving under the influence and drug-facilitated crime cases were analyzed using both methodologies and the results were compared. In addition, the cost of each methodology was evaluated and compared. The validated LC-MS-MS method had limits of detection that were equal to or lower than the concentrations validated for ELISA cutoffs, had fewer exogenous interferences, and the cost of screening per specimen was reduced by ~70% when compared to ELISA. Comparing the toxicology results of forensic urine specimens demonstrated that by only using ELISA, the laboratory was unable to detect benzoylecgonine in 26%, lorazepam in 33% and oxymorphone in 60% of the positive specimens. Additional analytes detected using the LC-MS-MS method were zolpidem and/or metabolite, gabapentin, tramadol and metabolite, methadone and metabolite, meprobamate and phentermine. The results of the validation, the toxicological result comparison and the cost comparison showed that the LC-MS-MS screening method is a simple, sensitive and cost-effective alternative to ELISA screening methods for urine specimens.

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Sulc, Miloslav, Marie Eliasova, Zora Kotikova, and Jaromir Lachman. "Validation of a UHPLC-ESI-MS/MS method for anthocyanidin quantification in potato tubers." Czech Journal of Food Sciences 35, No. 3 (June 28, 2017): 223–28. http://dx.doi.org/10.17221/389/2016-cjfs.

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The development of bioanalytical methods has become challenging due to sample complexity, requirements for method reliability, and speed of analysis with triple quadrupole LC-MS/MS used widely for the routine analysis of biological materials. The article presents the method development and validation results for pelargonidin and malvidin in potato tubers. The developed method uses a short C18 column, is able to measure all six common anthocyanidins, uses a binary mobile phase with acetonitrile and water both with added 1% formic acid, ESI ionisation in positive mode, 3-h hydrolysis with 2.7 M methanolic HCl at 90°C. For pelargonidin and malvidin, the method shows high recovery of 98–100%, intra-day repeatability of 6.7–17.9% (depending on the analyte and concentration level), uncertainty below 20%, and uses quadratic calibration.

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17

Riswahyuli, Riswahyuli, Loise RS, and Niza Nemara. "Multi Mycotoxins Analysis in Rice Using LC-MS/MS." MPI (Media Pharmaceutica Indonesiana) 1, no. 2 (April 11, 2017): 77–84. http://dx.doi.org/10.24123/mpi.v1i2.189.

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Multi mycotoxins analysis in this research has the purpose to develop method of analysisfor rice sample with a simple and fast preparation and novel technology using LC-MS/MS. Several blankrice samples were spiked with standards of 8 classes of mycotoxins (Aflatoxin B1, Aflatoxin B2, AflatoxinG1, Aflatoxin G2, Deoxynivalenol, Zearalenon, T-2, and HT-2). Parameter of linearity, precision, recovery,limit of detection and limit of quantification were obtained and calculated. The result shows that all thevalidation parameters comply with criteria of method validation. Sonication method that was chosen toextract analites and Solid Phase Extraction Column that used for sample clean up are successful methodsthat have contribution for precise and accurate data. The Identification and quantification with LC-MS/MS help to determine and distinguish each mycotoxin through chromatogram appearance, retention timeand a specific m/z.

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18

Velusamy, Shankarananth, Venkata Muralidhar Masimukku, Salini Chereddy, Jeevan Kumar Jadapalli, Keerthisikha Palur, Sreenivasa Charan Archakam, and Rajasekhar Komarla Kumarachari. "Bioanalytical method development and validation of rizatriptan in human plasma using LC–MS/MS method." International Journal of Chemical and Analytical Science 4, no. 2 (June 2013): 108–14. http://dx.doi.org/10.1016/j.ijcas.2013.03.009.

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19

Tak, Sung-Kwon, Ji-Hyung Seo, Ju-Hee Ryu, Sang-Joon Choi, Myung-Jae Lee, Jong-Min Kang, Jin-Sung Lee, Seung-Jae Hong, Sung-Vin Yim, and Kyung-Tae Lee. "Validation of LC-MS/MS Method for Determination of Rabeprazole in Human Plasma : Application of Pharmacokinetics Study." Journal of Korean Pharmaceutical Sciences 39, no. 1 (February 20, 2009): 73–78. http://dx.doi.org/10.4333/kps.2009.39.1.073.

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20

Qiu, Feng, Xiaoping Zhao, Xuran Lu, Manyuan Wang, and Muxin Gong. "HPLC-ESI-MS/MS validation and pharmacokinetics of kalopanaxsaponin A in rats." RSC Advances 5, no. 10 (2015): 7260–66. http://dx.doi.org/10.1039/c4ra14264k.

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21

Benton, Sally C., Godwin K. Tetteh, Sarah-Jayne Needham, Jakob Mücke, Leanne Sheppard, Steven Alderson, Corinne Ruppen, Maurus Curti, Maurice Redondo, and Anna M. Milan. "Evaluation of the 25-hydroxy vitamin D assay on a fully automated liquid chromatography mass spectrometry system, the Thermo Scientific Cascadion SM Clinical Analyzer with the Cascadion 25-hydroxy vitamin D assay in a routine clinical laboratory." Clinical Chemistry and Laboratory Medicine (CCLM) 58, no. 6 (June 25, 2020): 1010–17. http://dx.doi.org/10.1515/cclm-2019-0834.

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AbstractBackgroundLiquid chromatography-tandem mass spectrometry (LC-MS/MS) offers advantages over immunoassay due to its increased specificity and ability to multiplex metabolites within a single run. Wide scale adoption of LC-MS/MS in routine clinical laboratories is restricted in part due to the high level of technical expertise required. The Thermo Scientific™ Cascadion™ SM Clinical Analyzer is the first fully automated, random access clinical analyser that utilises LC-MS/MS technology. We report an analytical validation of the 25-hydroxy vitamin D2 and D3 assays on the Cascadion Analyzer and an assessment of its performance within a routine clinical laboratory.MethodsAnalyser usability was assessed by staff with no previous experience of LC-MS/MS. An analytical validation included analysis of 154 patient samples on two different Cascadion Analyzers and a four-way method comparison of 146 patient samples on Roche and Siemens immunoassays and an in-house LC-MS/MS method. Accuracy was assessed using external quality assurance and reference materials. Seven third party IQC materials were tested on Cascadion.ResultsCascadion proved easy to use by scientific and non-scientific staff. The assay passed all validation criteria. Excellent agreement was demonstrated between two different Cascadions (y = 0.97x + 3.9 nmol/L, r2 > 0.99). A method comparison demonstrated no significant difference (p > 0.05) between the Cascadion and the Roche immunoassay. A significant difference (p < 0.0001) was observed between the Cascadion and an LC-MS/MS and Siemens methods. Results obtained from EQA and reference material showed a mean bias of +3.09% and all samples were within ±10% of assigned concentrations. All third party IQC samples tested were compatible for use with Cascadion.ConclusionsThe Cascadion Analyzer is a fully automated LC-MS/MS system that requires no prior LC-MS/MS expertise. The vitamin D assays demonstrated excellent performance with high levels of accuracy.

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22

Gu, Sun Young, Han Sol Lee, Ji-Su Park, Su Jung Lee, Hye-Sun Shin, Sung Eun Kang, Yun Mi Chung, et al. "Determination and Validation of an Analytical Method for Dichlobentiazox in Agricultural Products with LC-MS/MS." Korean Journal of Environmental Agriculture 40, no. 2 (June 30, 2021): 108–17. http://dx.doi.org/10.5338/kjea.2021.40.2.13.

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Zhou, Rui, Fang Tang, Sanwang Li, Xiang Xie, Jie Peng, Feifan Xie, Lingli Mu, and Peng Yu. "A sensitive LC-ESI-MS/MS method for the determination of clotrimazole in human plasma." Analytical Methods 7, no. 16 (2015): 6672–77. http://dx.doi.org/10.1039/c5ay00729a.

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Felli, Marialinda, Fabio De-Giorgio, and Nadia De-Giovanni. "LC-MS/MS Determination of Bromperidol in Biological Matrices: Method Validation and Forensic Application." Current Pharmaceutical Analysis 7, no. 4 (November 1, 2011): 235–39. http://dx.doi.org/10.2174/157341211797458023.

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Kuchipudi, Anjali, Suganthi Angappan, and Bhuvaneswari Kaithamalai. "Method Validation, Dissipation and Decontamination of Flubendiamide Residues in Lettuce using LC/MS/MS." Pesticide Research Journal 31, no. 1 (2019): 34. http://dx.doi.org/10.5958/2249-524x.2019.00009.8.

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Ares, Ana M., Silvia Valverde, José L. Bernal, María J. Nozal, and José Bernal. "Development and validation of a LC–MS/MS method to determine sulforaphane in honey." Food Chemistry 181 (August 2015): 263–69. http://dx.doi.org/10.1016/j.foodchem.2015.02.085.

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Müller, Alexander, Dirk Flottmann, Wolfgang Schulz, Wolfram Seitz, and Walter H. Weber. "Alternative Validation of a LC-MS/MS-Multi-Method for Pesticides in Drinking Water." CLEAN – Soil, Air, Water 35, no. 4 (September 2007): 329–38. http://dx.doi.org/10.1002/clen.200700014.

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Strickland, Erin C., Oneka T. Cummings, Allyson L. Mellinger, and Gregory L. McIntire. "Development and Validation of a Novel All-Inclusive LC–MS-MS Designer Drug Method." Journal of Analytical Toxicology 43, no. 3 (November 14, 2018): 161–69. http://dx.doi.org/10.1093/jat/bky087.

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Fruehwirth, Sarah, Lisa Call, Fabiola Abigail Maier, Vanessa Hebenstreit, Stefano D’Amico, and Marc Pignitter. "LC–MS/MS method validation for the quantitation of 1-kestose in wheat flour." Journal of Food Composition and Analysis 100 (July 2021): 103930. http://dx.doi.org/10.1016/j.jfca.2021.103930.

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Protasiuk, Edyta, and Małgorzata Olejnik. "Determination of salicylic acid in feed using LC-MS/MS." Journal of Veterinary Research 62, no. 3 (October 23, 2018): 303–7. http://dx.doi.org/10.2478/jvetres-2018-0044.

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AbstractIntroductionSalicylic acid is a derivative of benzoic acid and occurs in nature. The main target of this study was to develop the liquid chromatography coupled with tandem mass spectrometry technique as a method for determination of salicylic acid in feed materials and compound feed.Material and MethodsSalicylic acid was extracted from feed with 0.1% hydrochloric acid in methanol. Separation was achieved in 8 min in a gradient elution using 0.1% formic acid and acetonitrile. The analyte was detected using negative electrospray tandem mass spectrometry. The procedure was validated to the specifications of the European Commission Decision No. 2002/657/EC.ResultsThe validation results showed the repeatability of the method, which was evaluated at three levels (0.25, 0.5, and 1.0 mg/kg). Calibration curves for the working ranges were linear (R2 0.9911 to 0.9936), and recoveries ranged from 98.3% to 101%. The LOD and LOQ for compound feed were 0.02 and 0.05 mg/kg, respectively. Salicylic acid was found mostly in corn, and its concentrations differed depending on whether it was young or fully grown (5.30–12.8 mg/kg and 0.13–1.01 mg/kg, respectively).ConclusionsA sensitive and reliable method for the determination of salicylic acid in feed and compound feed using LC-MS/MS was developed.

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Hösli, Raphael, Stefan König, and Stefan F. Mühlebach. "Development and Validation of an LC-MS/MS Method and Comparison with a GC-MS Method to Measure Phenytoin in Human Brain Dialysate, Blood, and Saliva." Journal of Analytical Methods in Chemistry 2018 (2018): 1–8. http://dx.doi.org/10.1155/2018/8274131.

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Phenytoin (PHT) is one of the most often used critical dose drugs, where insufficient or excessive dosing can have severe consequences such as seizures or toxicity. Thus, the monitoring and precise measuring of PHT concentrations in patients is crucial. This study develops and validates an LC-MS/MS method for the measurement of phenytoin concentrations in different body compartments (i.e., human brain dialysate, blood, and saliva) and compares it with a formerly developed GC-MS method that measures PHT in the same biological matrices. The two methods are evaluated and compared based on their analytical performance, appropriateness to analyze human biological samples, including corresponding extraction and cleanup procedures, and their validation according to ISO 17025/FDA Guidance for Industry. The LC-MS/MS method showed a higher performance compared with the GC-MS method. The LC-MS/MS was more sensitive, needed a smaller sample volume (25 µL) and less chemicals, was less time consuming (cleaning up, sample preparation, and analysis), and resulted in a better LOD (<1 ng/mL)/LOQ (10 ng/mL). The calibration curve of the LC-MS/MS method (10–2000 ng/mL) showed linearity over a larger range with correlation coefficients r2 > 0.995 for all tested matrices (blood, saliva, and dialysate). For larger sample numbers as in pharmacokinetic/pharmacodynamic studies and for bedside as well as routine analyses, the LC-MS/MS method offers significant advantages over the GC-MS method.

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Mastrovito, Rebecca A., Donna M. Papsun, and Barry K. Logan. "The Development and Validation of a Novel Designer Benzodiazepines Panel by LC–MS-MS." Journal of Analytical Toxicology 45, no. 5 (January 21, 2021): 423–28. http://dx.doi.org/10.1093/jat/bkab013.

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Abstract Novel illicit benzodiazepines are among the most active areas of new illicit drug manufacture and use. We describe a method for the detection and quantification of etizolam and its metabolite α-hydroxyetizolam, flubromazolam, clonazolam, diclazepam, delorazepam, bromazepam, flubromazepam, phenazepam, flualprazolam, flunitrazolam, and nitrazolam in human whole blood. After addition of internal standards, samples are buffered and extracted using a liquid–liquid extraction. Analysis is performed using positive-ion electrospray tandem mass spectrometry for detection and quantitation. Calibration ranges were established based on the method performance and differed from compound to compound. Replicates at the lowest calibration point for each compound performed within 5% of CV (Coefficient of Variation). The correlation coefficient was >0.990 for all compounds. Relative standard deviation for all compounds was ≤10% of CV and accuracy was ±10% for both within- and between-run experiments. The maximum average intra- and inter-run imprecision were 5.7%. The maximum average intra- and inter-run imprecision was −8.7%. As part of evaluating the scope for relevancy, samples testing positive in immunoassay but confirmed to be negative in traditional benzodiazepine confirmation method were re-analyzed using this method. The presence of at least one novel benzodiazepine was identified in 70% of these samples. The appearance of these novel “designer” benzodiazepines demonstrates the challenge for toxicology testing and the need for continually updated confirmation methods.

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Lee, Ji Hyun, Han Na Park, Hyoung-Joon Park, Seok Heo, Seong Soo Park, Sung-Kwan Park, and Sun Young Baek. "Development and Validation of LC–MS/MS and LC-Q-Orbitrap/MS Methods for Determination of Glyphosate in Vaccines." Chromatographia 80, no. 12 (October 26, 2017): 1741–47. http://dx.doi.org/10.1007/s10337-017-3417-9.

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McNabb, Paul S., Andrew I. Selwood, Roel van Ginkel, Michael Boundy, and Patrick T. Holland. "Determination of Brevetoxins in Shellfish by LC/MS/MS: Single-Laboratory Validation." Journal of AOAC INTERNATIONAL 95, no. 4 (July 1, 2012): 1097–105. http://dx.doi.org/10.5740/jaoacint.11-272.

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Abstract A single-laboratory validation is reported for an LC/MS/MS quantification of six brevetoxins in four matrixes (GreenshellTM mussel, eastern oyster, hard clam, and Pacific oyster). Recovery and precision data were collected from seven analytical batches using shellfish flesh at 0.05 mg/kg. Method recoveries and within-laboratory reproducibility ranged from 73 to 112%, with an RSD between 14 and 18% for brevetoxin-3, brevetoxin B5, brevetoxin B2, and S-desoxy brevetoxin B2. The recovery and within-laboratory reproducibility for brevetoxin-2 was 61%, with an RSD of 27%. Brevetoxin B1 gave an RSD of 12%, but no reference material was available and this toxin was only recorded in a hard clam sample naturally contaminated with brevetoxins. One naturally contaminated sample of each shellfish matrix, with brevetoxin levels ranging from 0.012 to 9.9 mg/kg, was tested in multiple batches, and the RSDs were similar to those for fortified samples at 0.05 mg/kg. Comparisons with limited data for the neurotoxic shellfish poisoning mouse bioassay for four naturally contaminated shellfish samples showed that the regulatory action limit of 0.8 mg/kg is conservative with respect to the bioassay regulatory limit of 20 mouse units/100 g.

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Jenkins, Rand, Jeffrey X. Duggan, Anne-Françoise Aubry, Jianing Zeng, Jean W. Lee, Laura Cojocaru, Dawn Dufield, et al. "Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics." AAPS Journal 17, no. 1 (November 13, 2014): 1–16. http://dx.doi.org/10.1208/s12248-014-9685-5.

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Kumar, Anil, Kanakapura Basavaiah, Kalsang Tharpa, and Kanakapura Vinay. "Determination of raloxifene hydrochloride in human urine by LC-MS-MS." Chemical Industry and Chemical Engineering Quarterly 15, no. 3 (2009): 119–23. http://dx.doi.org/10.2298/ciceq0903119k.

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A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC-MS-MS) method was developed to determine raloxifene hydrochloride (RLX) in human urine. After a solid-phase extraction with SPE cartridge, the urine sample was analyzed on a C18 column (Symmetry 3.5?m; 50 mm?4.6 mm i.d) interfaced with a triple quadruple tandem mass spectrometer. A positive electrospray ionization was employed as the ionization source. The mobile phase consisted of ammonium acetate (pH 4.0)-acetonitrile (60:40, v/v).The method was linear over a concentration range of 20-1000 ng mL-1. The lower limit of quantitation was 20 ng mL-1. The intra-day and inter-day relative standard deviation across three validation runs over the entire concentration range was <10.5%. The accuracy determined at three concentrations (50, 500 and 850 ng mL-1 RLX) was within ?0.84% in terms of relative errors.

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Velamakanni, Satish Ramanatham, and Venkateswarlu Padala. "ESTIMATION OF ETONOGESTREL IN HUMAN PLASMA BY USING LC–ESI–MS/MS METHOD." International Journal of Pharmacy and Pharmaceutical Sciences 9, no. 12 (December 1, 2017): 147. http://dx.doi.org/10.22159/ijpps.2017v9i12.20946.

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Objective: The aspiration of the present study was to develop simple, robust and reliable liquid chromatography/electro spray ionization tandem mass spectrometry (LC-MS/MS) (Agilent Technologies) assay method for the quantification of etonogestrel in human serum by using etonogestrel d6 as internal standard (IS).Methods: An easy Liquid-Liquid Extraction (LLE) sample processing method was used to extract etonogestrel from plasma and chromatographic method was developed with run time 3.5min with linear calibration curve ranges from 50-3604 pg/mL for both etonogestrel and etonogestrel d6 and chromatographic method validated by determining carryover test, sensitivity, matrix effect, linearity, precision, accuracy, recovery, dilution integrity and stability. The developed method was used for pharmacokinetic study of 75mcg desogestrel tablet formulation under fasting condition in healthy females.Results: The validation showed the developed method was accurate with the results of validated parameters were met acceptance criteria as per Food and Drug Administration (FDA) guidelines. The validated method successfully was used for pharmacokinetic study of 75mcg desogestrel tablet in healthy females and quantified the amount of etonogestrel and IS.Conclusion: The developed method for etonogestrel in human plasma has been validated and used in pharmacokinetic studies.

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Do, Jung-Ah, Mi-Young Lee, Yoon-Jae Cho, Iil-Hyun Kang, Kisung Kwon, and Jae-Ho Oh. "Development and validation of an analytical method for pyrimisulfan determination in agricultural commodities by LC-MS/MS." Analytical Science and Technology 26, no. 2 (April 25, 2013): 154–63. http://dx.doi.org/10.5806/ast.2013.26.2.154.

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Kellie, John F., Yun W. Alelyunas, Josh Albert, Nicole A. Schneck, Zhuo Chen, Caroline J. Sychterz, Ian Edwards, Henry Shion, Mark D. Wrona, and Matthew E. Szapacs. "Intact mAb LC–MS for drug concentration from pre-clinical studies: bioanalytical method performance and in-life samples." Bioanalysis 12, no. 19 (October 2020): 1389–403. http://dx.doi.org/10.4155/bio-2020-0168.

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Background: Antibody biotherapeutic measurement from pharmacokinetic studies has not been traditionally based on intact molecular mass as is the case for small molecules. However, recent advancements in protein capture and mass spectrometer technology have enabled intact mass detection and quantitation for dosed biotherapeutics. A bioanalytical method validation is part of the regulatory requirement for sample analysis to determine drug concentration from in-life study samples. Results/methodology: Here, an intact protein LC–MS assay is subjected to mock bioanalytical method validation, and unknown samples are compared between intact protein LC–MS and established bioanalytical assay formats: Ligand-binding assay and peptide LC–MS/MS. Discussion/conclusion: Results are presented from the intact and traditional bioanalytical method evaluations, where the in-life sample concentrations were comparable across method types with associated data analyses presented. Furthermore, for intact protein LC–MS, modification monitoring and evaluation of data processing parameters is demonstrated.

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Nakov, Natalija, Kristina Mladenovska, Dimche Zafirov, Aleksandar Dimovski, Rumenka Petkovska, Aneta Dimitrovska, and Zoran Kavrakovski. "High-throughput SPE-LC-MS/MS method for determination of indapamide in human serum." Macedonian Pharmaceutical Bulletin 59 (February 2013): 15–22. http://dx.doi.org/10.33320/maced.pharm.bull.2013.59.002.

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Simple, automated SPE procedure combined with fast LC-MS/MS chromatographic separation resulted in obtaining high-throughput LC-MS/MS method for determination of indapamide in serum. The SPE procedure was performed on polymeric mixed-mode sorbent and the analytes were quantitated using electrospray ionization in positive mode. The recovery of indapamide and internal standard were 89.25- 90.36% and 79.10%, respectively. Experimentally it was confirmed that the matrix effect had a negligible effect of ionization efficiency. The validation data showed that the proposed method provides accurate and reproducible results in range of 0.50-50 ng/mL. In addition, a comparison was made between the method for determination of indapamide in serum and in blood (develop in our previously work) regarding the extraction procedure and matrix effect.

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Yi, Xin, Edward Ki Yun Leung, Rachael Bridgman, Selene Koo, and Kiang-Teck J. Yeo. "High-Sensitivity Micro LC-MS/MS Assay for Serum Estradiol without Derivatization." Journal of Applied Laboratory Medicine 1, no. 1 (July 1, 2016): 14–24. http://dx.doi.org/10.1373/jalm.2016.020362.

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Abstract Background There are considerable demands to accurately measure estradiol (E2) at low concentrations (<20 pg/mL) in postmenopausal women, men, pediatric patients, and patients receiving breast cancer treatment. Most current high-sensitivity LC-MS/MS E2 methods require large sample volumes and involve complex sample preparations with dansyl chloride derivatization. Our study aims to develop a high-sensitivity, underivatized method using micro LC-MS/MS to reliably measure E2 concentrations below 5 pg/mL by the use of low sample volume. Methods A total of 290 μL of sample was mixed with internal standard (IS), E2-d4, and extracted with a mixture of hexane/ethyl acetate (90/10) (v/v). After extraction, sample was separated by Eksigent Ekspert™ micro LC 200 system with a flow rate of 35 μL/min in a total run time of 3.5 min and detected by SCIEX QTRAP 6500 mass spectrometer in a negative mode using transitions: 271/145 (quantifier) and 271/143 (qualifier). In this method, it was crucial to use HPLC columns with stability at a pH >10. Results The validation study demonstrated broad linear ranges (3.0–820.0 pg/mL) with r2 > 0.999. Total precision was below 15% at all QC levels, and limit of quantification (LOQ) was 3.0 pg/mL. Our method showed good correlation with E2 RIA (r2 = 0.96, bias = −1.0 pg/mL) and modest correlation with E2 Roche Cobas automated immunoassay (r2 = 0.86, bias = 6.0 pg/mL). Conclusions In conclusion, we developed and validated a routinely applicable micro LC-MS/MS method without derivatization for E2 in blood samples with an LOQ of 3.0 pg/mL.

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Ferreira, Mônica Siqueira, Cláudio Roberto Marquez, Danieli Almeida dos Santos, José Jorge Gabbai, Aline Cristina Martho, Amanda Hayashi Yamanouchi Brandão, Kleyton Arlindo Barella, Maria Francesca Riccio, Ana Cláudia Noboli, and Pedro Serafim Júnior. "Validation of direct method to quantify dexamethasone in human aqueous humor by LC–MS/MS." Bioanalysis 10, no. 17 (September 2018): 1361–70. http://dx.doi.org/10.4155/bio-2018-0079.

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Zhang, Jie, Shimin Wei, David W. Ayres, Harold T. Smith, and Francis LS Tse. "An automation-assisted generic approach for biological sample preparation and LC–MS/MS method validation." Bioanalysis 3, no. 17 (September 2011): 1975–86. http://dx.doi.org/10.4155/bio.11.178.

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Kachave, Ramanlal N., Mayura Kale, and Rajendra D. Wagh. "Development and Validation of a LC-MS/MS Method to Determine Lansoprazole in Human Plasma." Open Analytical Chemistry Journal 8, no. 1 (April 27, 2015): 7–11. http://dx.doi.org/10.2174/1874065001508010007.

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Jain, Pritam S., Kajal D. Bobade, Pankaj R. Bari, Devendra S. Girase, and Sanjay J. Surana. "Development and validation of analytical method for Naftopidil in human plasma by LC–MS/MS." Arabian Journal of Chemistry 8, no. 5 (September 2015): 648–54. http://dx.doi.org/10.1016/j.arabjc.2013.06.020.

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Rajput, Mithlesh, Meenakshi Dahiya, Premlata Kumari, Kamini Kalra, Manjeet Aggarwal, and R. K. Khandal. "Method Development and Validation for Determination of Voglibose in Tablet Formulation Using LC-MS/MS." E-Journal of Chemistry 8, no. 4 (2011): 1770–83. http://dx.doi.org/10.1155/2011/531762.

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Voglibose is a potent α glucosidase inhibitor, used for the treatment of diabetes mellitus. For quantitative determination of voglibose in pharmaceutical formulations of low doses, simple, sensitive, accurate and precise LC-MS/MS method using electrospray ionization in positive mode was developed and validated. The method was found linear in the concentration range of 25.0-1200 ηg/mL with a correlation coefficient of 0.9998. The limit of detection (LOD) of the method was found to be 1.5 ηg/mL and limit of quantitation (LOQ) was achieved at 3.0 ηg/mL. The recoveries of voglibose from spiked samples at different concentration levels were found in the range of 98-102%. The proposed method was found suitable for quantitation of voglibose and for the determination of uniformity of content of the dosage units of the tablet formulations.

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Schmidt, B., H. B. Christensen, A. Petersen, J. J. Sloth, and M. E. Poulsen. "Method validation and analysis of nine dithiocarbamates in fruits and vegetables by LC-MS/MS." Food Additives & Contaminants: Part A 30, no. 7 (July 2013): 1287–98. http://dx.doi.org/10.1080/19440049.2013.801083.

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Goswami, Dipanjan, Ajay Kumar, Arshad H. Khuroo, Tausif Monif, and Shamsur Rab. "Bioanalytical LC-MS/MS method validation for plasma determination of topiramate in healthy Indian volunteers." Biomedical Chromatography 23, no. 11 (November 2009): 1227–41. http://dx.doi.org/10.1002/bmc.1273.

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Binhashim, Nada H., Syed N. Alvi, and Muhammad M. Hammami. "LC-MS/MS Method for Determination of Colistin in Human Plasma: Validation and Stability Studies." International Journal of Analytical Mass Spectrometry and Chromatography 09, no. 01 (2021): 1–11. http://dx.doi.org/10.4236/ijamsc.2021.91001.

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Marin, Clémence, Nihel Khoudour, Aurélien Millet, Dorothée Lebert, Pauline Bros, Fabienne Thomas, David Ternant, et al. "Cross-Validation of a Multiplex LC-MS/MS Method for Assaying mAbs Plasma Levels in Patients with Cancer: A GPCO-UNICANCER Study." Pharmaceuticals 14, no. 8 (August 12, 2021): 796. http://dx.doi.org/10.3390/ph14080796.

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Background: Different liquid chromatography tandem mass spectrometry (LC–MS/MS) methods have been published for quantification of monoclonal antibodies (mAbs) in plasma but thus far none allowed the simultaneous quantification of several mAbs, including immune checkpoint inhibitors. We developed and validated an original multiplex LC–MS/MS method using a ready-to-use kit to simultaneously assay 7 mAbs (i.e., bevacizumab, cetuximab, ipilimumab, nivolumab, pembrolizumab, rituximab and trastuzumab) in plasma. This method was next cross-validated with respective reference methods (ELISA or LC–MS/MS). Methods: The mAbXmise kit was used for mAb extraction and full-length stable-isotope-labeled antibodies as internal standards. The LC–MS/MS method was fully validated following current EMA guidelines. Each cross validation between reference methods and ours included 16–28 plasma samples from cancer patients. Results: The method was linear from 2 to 100 µg/mL for all mAbs. Inter- and intra-assay precision was <14.6% and accuracy was 90.1–111.1%. The mean absolute bias of measured concentrations between multiplex and reference methods was 10.6% (range 3.0–19.9%). Conclusions: We developed and cross-validated a simple, accurate and precise method that allows the assay of up to 7 mAbs. Furthermore, the present method is the first to offer a simultaneous quantification of three immune checkpoint inhibitors likely to be associated in patients.

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