AN LC-MS/MS METHOD FOR SIMULTANEOUS QUANTIFICATION OF PARACETAMOL AND PAMABROM IN HUMAN PLASMA
Abstract
Back pain and menstruation pain are generally treated with a combination of paracetamol (PCM) and pamabrom (PAMA). In this study, a liquid chromatography/tandem mass spectrometry (LC-MS/MS) method for the simultaneous quantification of PCM and PAMA from human plasma is developed and validated for the first time. The analytes and the internal standard (IS), diclofenac, were eluted on a kromasil C18 (100 x 4.6 mm, 5 μm) column using a simple optimized mobile phase after being treated by liquid-liquid extraction. Using the electrospray ionization technique, quantification was carried out using a hyphenated tandem mass spectrometer with a flow rate of 0.4 mL/min and completing the entire run time within 4 minutes. For PCM and PAMA, the calibration curve was linear (r > 0.995) for the range of 40–8000 ng/mL and 20–4000 ng/mL, respectively. This method produced reliable findings since it was verified for specificity, accuracy, recovery, linearity, precision, matrix effect, and stability investigations, and the results were determined to be within acceptable parameters. The current study’s findings demonstrated that this technology’s simplicity, rapidity, and sensitivity allow for routine usage in exploratory or clinical monitoring of both medications in human plasma.
Keywords:
Human Plasma, LC-MS/MS, Paracetamol, Pamabrom, ValidationDOI
https://doi.org/10.25004/IJPSDR.2022.140515References
Rang HP, Ritter JM, Flower RJ, Henderson G. Rang & Dale's Pharmacology. 5th edition (India) ed. New Delhi: Elsevier; 2005. 244-52 p.
Mudge GH, Weiner IM. The mechanism of action of mercurial and xanthine diuretics. Annals of the New York Academy of Sciences. 1958;71(4):344-54. 10.1111/j.1749-6632.1958.tb46761.x.
Turley SM. Understanding Pharmacology for Health Professionals: Pearson Education; 2014.
Nagaralli BS, Seetharamappa J, Gowda BG, Melwanki MB. Liquid chromatographic determination of ceterizine hydrochloride and paracetamol in human plasma and pharmaceutical formulations. Journal of Chromatography B. 2003;798(1):49-54. http://dx.doi. org/10.1016/j.jchromb.2003.08.048.
Ing-Lorenzini KR, Desmeules JA, Besson M, Veuthey J-L, Dayer P, Daali Y. Two-dimensional liquid chromatography–ion trap mass spectrometry for the simultaneous determination of ketorolac enantiomers and paracetamol in human plasma: Application to a pharmacokinetic study. Journal of Chromatography A. 2009;1216(18):3851-6. ht tp://dx.doi .org/10.1016/j . chroma.2009.02.071.
Chen X, Huang J, Kong Z, Zhong D. Sensitive liquid chromatography– tandem mass spectrometry method for the simultaneous determination of paracetamol and guaifenesin in human plasma. Journal of Chromatography B. 2005;817(2):263-9. http://dx.doi. org/10.1016/j.jchromb.2004.12.011.
Celma C, Allue JA, Prunonosa J, Peraire C, Obach R. Simultaneous determination of paracetamol and chlorpheniramine in human plasma by liquid chromatography-tandem mass spectrometry. Journal of Chromatography A. 2000;870(1-2):77-86. 10.1016/ s0021-9673(99)01252-2.
Lou HG, Yuan H, Ruan ZR, Jiang B. Simultaneous determination of paracetamol, pseudoephedrine, dextrophan and chlorpheniramine in human plasma by liquid chromatography-tandem mass spectrometry. Journal of chromatography B, Analytical technologies in the biomedical and life sciences. 2010;878(7-8):682-8. 10.1016/j. jchromb.2010.01.005.
Mohamed D, Hegazy MA, Elshahed MS, Toubar SS, Helmy MI. Liquid chromatography–tandem MS/MS method for simultaneous quanti¬fication of paracetamol, chlorzoxazone and aceclofenac in human plasma: An application to a clinical pharmacokinetic study. Bio¬medical Chromatography. 2018;32(7):e4232. 10.1002/bmc.4232.
Idris M, John C, Ghosh P, Shukla SK, Baggi TRR. Simultaneous determination of methaqaulone, saccharin, paracetamol, and phenacetin in illicit drug samples by HPLC. Journal of Analytical Science and Technology. 2013;4(1):4. 10.1186/2093-3371-4-4.
Shah U, Kavad M, Raval M. Development and Validation of Stability-indicating RP-HPLC Method for Estimation of Pamabrom in Tablets. Indian Journal of Pharmaceutical Sciences. 2014;76(3):198-202.
Jun H-S, Kang J-S, Park J-S, Cho C-W. Simultaneous analysis of ibuprofen and pamabrom by HPLC. Journal of Pharmaceutical Investigation. 2015;45(6):555-60. 10.1007/s40005-015-0203-2.
González-de la Parra M, Lucio-Maldonado S, Cruz-Salinas MA, López-Bojórquez E, Pérez-Becerril F, Burke-Fraga V. Bioanalytical Method for Pamabrom (Determined as 8-Bromotheophylline) and its Application to a Pharmacokinetic Study. Journal of Bioequivalence Studies. 2017;3(1):1-8. 10.15744/2575-551X.3.101.
Bambhrolia S, Rajput SJ. Simultaneous estimation of Paracetamol and Pamabrom in bulk drugs and in pharmaceutical formulation by spectrophotometry. International Journal of ChemTech Research. 2013;5(4):1802-7.
Salem H, Mohamed D. Simultaneous determination of pamabrom and paracetamol in bulk powders and womankit tablet using spectrophotometric and chemometric-assisted spectrophotometric methods. Analytical Chemistry: An Indian Journal. 2013;13(1):6-16.
Abdelaleem EA, Naguib IA, Hassan ES, Ali NW. Development and Validation of Three Spectrophotometric Methods for Simultaneous Determination of Paracetamol and Pamabrom in Bulk and Pharmaceutical Formulation. Analytical Chemistry Letters. 2016;6(1):13-23. 10.1080/22297928.2016.1138882.
Patel HH, Patel H. Development and validation of reverse phase high performance liquid chromatographic method for simultaneous estimation of paracetamol and pamabrom in combined dosage form. World Journal of Pharmacy and Pharmaceutical Sciences. 2014;3(Spec.Issue4):1303-13, 11.
Prajapati PP, Captain AD, Patel DS. Development and validation of HPTLC method for simultaneous determination of pamabrom and paracetamol in synthetic mixture. International Research Journal of Pharmacy. 2012;3(11):167-71.
Abdelaleem EA, Naguib IA, Hassan ES, Ali NW. HPTLC and RP-HPLC methods for simultaneous determination of Paracetamol and Pamabrom in presence of their potential impurities. Journal of pharmaceutical and biomedical analysis. 2015;114:22-7. 10.1016/j. jpba.2015.04.043.
El-Houssini OM. RP-LC and TLC densitometric determination of paracetamol and pamabrom in presence of hazardous impurity of paracetamol and application to pharmaceuticals. Analytical chemistry insights. 2013;8:73-81. 10.4137/ACI.S12349.
USFDA. Guidance for Industry- Bioanalytical method validation. U.S. Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM); May 2001.
Patel JR, Pethani TM, Vachhani AN, Sheth NR, Dudhrejiya AV. Development and validation of bioanalytical method for simultaneous estimation of ramipril and hydrochlorothiazide in human plasma using liquid chromatography-tandem mass spectrometry. Journal of Chromatography B. 2014;970:53-9. https:// doi.org/10.1016/j.jchromb.2014.08.023.
Zhou L-j, Gu L-h, Wang Y-j, Liang J-y. Determination of acetaminophen and pamabrom in compound tablets in human plasma by HPLC. Chinese Journal of New Drugs and Clinical Remedies 2007;3(3): 187-90.
Wang H, Jin X, Zhao L, Chen J, Lu L, Zhang G. Determination of paracetamol and pamabrom in human plasma and urine by LC/MS method. Pharmaceutical Care and Research. 2010;10(3):198-201.
Thummar K, Solanki P, Mardia R, Sheth N. Quantitative determination of lacosamide in human plasma using liquid chromatography-tandem mass spectrometry and its application to pharmacokinetic study. International Journal of Pharmaceutical Sciences & Research. 2021;12(1):321-29. 10.13040/ijpsr.0975-8232.12(1).321-29.
Thummar K, Jethva D, Sheth N. Quantitative analysis of Topiramate in human plasma using LC-MS/MS and it s application to pharmacokinetic study. World Journal of Pharmacy and Pharmaceutical Sciences. 2018;7(5):1016-32. 10.20959/ wjpps20185-11511.
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