Development and Validation of QbD-Driven Bioanalytical LC-MS/MS Method for the Quantification of Paracetamol and Diclofenac in Human Plasma

References

• Smith, H.S. (2011). Perioperative Intravenous Acetaminophen and NSAIDs. Pain Med. 12: 961–981. doi: 10.1111/j.1526-4637.2011.01141.x
   PubMed Web of Science ®Google Scholar
• Perrott, D.A., Piira, T., Goodenough, B., Champion, G.D. (2004). Efficacy and safety of acetaminophen vs ibuprofen for treating children’s pain or fever: a metaanalysis. Arch Pediatr Adolesc Med. 158: 521–526. doi: 10.1001/archpedi.158.6.521
   PubMed Web of Science ®Google Scholar
• Rao, R.N., Narasaraju, A. (2006). Rapid separation and determination of process-related substances of paracetamol using reversedphase HPLC with photo diode array as a detector. Anal. Sci. 22: 287–292. doi: 10.2116/analsci.22.287
   PubMed Web of Science ®Google Scholar
• Momin, M.Y., Yeole, P.G., Puranik, M.P., Wadher, S.J. (2006). Reverse phase HPLC method for determination of aceclofenac and paracetamol in tablet dosage form. Ind. J. Pharm. Sci. 68(3): 387–389. doi: 10.4103/0250-474X.26672
   Google Scholar
• Vertzoni, M.V., Archontaki, H.A., Galanopoulou, P. (2003). Development and optimization of a reversed-phase high-performance liquid chromatographic method for the determination of acetaminophen and its major metabolites in rabbit plasma and urine after a toxic dose. J. Pharm. Biomed. Anal. 32(2): 487–493. doi: 10.1016/S0731-7085(03)00246-2
   PubMedGoogle Scholar
• Campanero, M.A., Calahorra, B., Garciá-Quétglas, E., López-Ocáriz, A., Honorato, J. (1999). Rapid liquid chromatographic assay for the determination of acetaminophen in plasma after propacetamol administration: application to pharmacokinetic studies. J. Pharm. Biomed. Anal. 20: 327–334. doi: 10.1016/S0731-7085(99)00051-5
   PubMed Web of Science ®Google Scholar
• Lau, O.W., Luk, S.F., Cheung, Y.M. (1989). Simultaneous determination of ascorbic acid, caffeine and paracetamol in drug formulations by differential-pulse voltammetry using a glassy carbon electrode. Analyst. 114: 1047–1051. doi: 10.1039/an9891401047
   PubMed Web of Science ®Google Scholar
• Chen, X., Huang, J., Kong, Z., Zhon, D. (2005). Sensitive liquid chromatography-tandem mass spectrometry method for the simultaneous determination of paracetamol and guaifenesin in human plasma. J. Chromat. B Anal. Tech. Biomed. Life Sci. 817: 263–269. doi: 10.1016/j.jchromb.2004.12.011
   PubMed Web of Science ®Google Scholar
• Zhu, T., Ding, L., Guo, I.X., Yang, L., Wen, A. (2007). Simultaneous determination of tramadol and acetaminophen in human plasma by LC-ESI-MS. Chromat. 66: 171–178. doi: 10.1365/s10337-007-0268-9
   Web of Science ®Google Scholar
• Mahajan, V.K., Bari, S.B., Shirkhedkar, A.A., Surana, S.J. (2008). Simultaneous densitometric TLC analysis of aceclofenac, paracetamol and chlorzoxazone in tablets. Acta Chromat. 20: 625–636. doi: 10.1556/AChrom.20.2008.4.8
   Web of Science ®Google Scholar
• Hector, C.G., Alejandro, C.O. (1999). Simultaneous multivariate spectrophotometric analysis of paracetamol and minor components (diphenhydramine or phenylpropanolamine) in tablet preparations. J. Pharm. Biomed. Anal. 20(1-2): 255–261. doi: 10.1016/S0731-7085(99)00029-1
   PubMed Web of Science ®Google Scholar
• Yin, O.Q., Tomlinson, B., Chow, A.H., Chow, M.S. (2001). Pharmacokinetics of acetaminophen in Hong Kong Chinese subjects. Int. J. Pharm. 222: 305–308. doi: 10.1016/S0378-5173(01)00712-8
   PubMedGoogle Scholar
• Flores-Pérez, C., Chávez-Pacheco, J.L., Ramírez-Mendiola, B., Alemón-Medina, R., García-Álvarez, R., Juárez-Olguín, H., Flores-Pérez, J. (2010). A reliable method of liquid chromatography for the quantification of acetaminophen and identification of its toxic metabolite N-acetyl-p-benzoquinoneimine for application in pediatric studies. Biomed Chromat. 25: 760–766. doi: 10.1002/bmc.1511
   PubMed Web of Science ®Google Scholar
• Abu-Qare, A.W., Abou-Donia, M.B. (2001). A validated HPLC method for the determination of pyridostigmine bromide, acetaminophen, acetylsalicylic acid and caffeine in rat plasma and urine. J. Pharm. Biomed. Anal. 26: 939–947. doi: 10.1016/S0731-7085(01)00448-4
   PubMed Web of Science ®Google Scholar
• Alkharfy, K.M., Frye, R.F. (2001). High-performance liquid chromatographic assay for acetaminophen glucuronide in human liver microsomes. J. Chromat. B Biomed. Sci. Appl. 753: 303–308. doi: 10.1016/S0378-4347(00)00566-1
   PubMed Web of Science ®Google Scholar
• Brunner, L.J., Bai, S. (1999). Simple and rapid assay for acetaminophen and conjugated metabolites in low-volume serum samples. J. Chromat. B Biomed. Sci. Appl. 732: 323–329. doi: 10.1016/S0378-4347(99)00290-X
   PubMedGoogle Scholar
• Lufeng, H.U., Xuezhi, Y., Xianqin, W., Jiayin, Z., Shuhua, T., Gaozhong, C. (2009). Rapid LC-APCI-MS-MS method for simultaneous determination of phenacetin and its metabolite paracetamol in rabbit plasma. Chromat. 70: 585–590. doi: 10.1365/s10337-009-1163-3
   Web of Science ®Google Scholar
• Zhang, Y., Mehrotra, N., Budha, N.R., Christensen, M.L., Meibohm, B. (2008). A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens. Clin. Chim. Acta. 398: 105–112. doi: 10.1016/j.cca.2008.08.023
   PubMed Web of Science ®Google Scholar
• Johnson, K.A., Plumb, R. (2005). Investigating the human metabolism of acetaminophen using UPLC and exact mass oa-TOF MS. J. Pharm. Biomed. Anal. 39: 805–810. doi: 10.1016/j.jpba.2005.04.048
   PubMed Web of Science ®Google Scholar
• Seth, S.D., Seth, V. (1998). Textbook of pharmacology. 3rd ed. Elsevier, Noida.
   Google Scholar
• De Souza, R.L., Tubino, M. (2005). Spectrophotometric determination of diclofenac in pharma-ceutical preparations. J. Braz. Chem. Soc. 16(5): 1068–1073. doi: 10.1590/S0103-50532005000600026
   Web of Science ®Google Scholar
• Kormosh, Z.O., Hunka, I.P., Bazel, Y.R. (2008). Extraction and spectrophotometric determination of diclofenac in pharmaceuticals. J. Chin. Chem. Soc. 55: 356–361. doi: 10.1002/jccs.200800052
   Web of Science ®Google Scholar
• Ciapina, E.G., Santini, A.O., Weinert, P.L., Gotardo, M.A., Pezza, H.R., Pezza, L. (2005). Spectrophotometric determination of diclofenac in pharmaceutical preparations assisted by microwave oven. Eclet. Quím. 30(1): 29–36. doi: 10.1590/S0100-46702005000100004
   Google Scholar
• Rodriguez, J.A., Islas, G., Paez-Hernandez, M.E., Barrado, E. (2008). Sequential injection spectrophotometric determination of diclofenac in urine and pharmaceutical formulations. J. Flow Injec. Anal. 25(1): 39–43.
   Google Scholar
• Panda, S.S., Patanaik, D., Kumar, B.R. (2012). New Stability-Indicating RP-HPLC method for determination of diclofenac potassium and metaxalone from their Combined Dosage Form. Sci. Pharm. 80(1): 127–137. doi: 10.3797/scipharm.1109-16
   PubMedGoogle Scholar
• Muntean, D., Vlase, L., Ciciureanu, R., Ciciureanu, M. (2011). LC-MS/MS method for quantification of diclofenac from human plasma and its application to pharmakokinetics studies. Rev. Roum. Chim. 56(1): 19–24.
   Web of Science ®Google Scholar
• Emami, J., Ghassami, N., Talari, R. (2007). A rapid and sensitive modified HPLC method for determination of diclofenac in human plasma and its application in pharmacokinetic studies. DARU. 15(3): 132–138.
   Google Scholar
• Mohammad, A., Sharma, S. (2009). Separation of co-existing paracetamol and diclofenac sodium on silica gel ‘H’ layers using surfactant mediated mobile phase: identification of diclofenac sodium from human urine. Farmacia. 57(2): 201–211.
   Web of Science ®Google Scholar
• Ensafi, A.A., Izadi, M., Karimi-Maleh, H. (2013). Sensitive voltammetric determination of diclofenac using room-temperature ionic liquid-modified carbon nanotubes paste electrode. Ionics. 19(1): 137–144. doi: 10.1007/s11581-012-0705-0
   Web of Science ®Google Scholar
• Chethana, B.K., Basavanna, S., Arthoba, N.Y. (2012). Voltammetric determination of diclofenac sodium using tyrosine-modified carbon paste electrode. Ind. Eng. Chem. Res. 1(31): 10287–10295. doi: 10.1021/ie202921e
   Google Scholar
• Hassan, S.S.M., Mahmoud, W.H., Elmosallamy, M.A.F., Almarzooqi, M.H. (2005). Iron (II) phthalocyanine as a novel recognition sensor for selective potentiometric determination of diclofenac and warfarin drugs. J. Pharm. Biomed. Anal. 39(12): 315–321. doi: 10.1016/j.jpba.2005.03.027
   PubMedGoogle Scholar
• Mokhtaria, A., Karimi-Malehb, H., Ensafic, A.A., Beitollahi, H. (2012). Application of modified multiwall carbon nanotubes paste electrode for simultaneous voltammetric determination of morphine and diclofenac in biological and pharmaceutical samples. Sens. Actuat. Chem. 169: 96–105. doi: 10.1016/j.snb.2012.03.059
   Web of Science ®Google Scholar
• Aneshgar, P.D., Norouzi, P., Ganjali, M.R., Dinarvand, R., Moosavi-Movahedi, A.A. (2009). Determination of diclofenac on a dysprosium nanowiremodified carbon paste electrode accomplished in a flow injection system by advanced filtering. Sensors. 9(10): 7903–7918. doi: 10.3390/s91007903
   PubMed Web of Science ®Google Scholar
• Ji, W., Zhan, J. (2000). Determination of diclofenac sodium by capillary zone electrophoresis with electrochemical detection. J. Chromat. A. 868(1): 101–107. doi: 10.1016/S0021-9673(99)01149-8
   PubMed Web of Science ®Google Scholar
• Hasnain, M.S., Rao, S., Singh, M.K., Vig, N., Gupta, A., Ansari, A., Sen, P., Joshi, P., Ansari, S.A. (2013). Development and validation of LC-MS/MS method for the quantitation of lenalidomide in human plasma using Box–Behnken experimental design. Analyst. 138: 1581. doi: 10.1039/c2an36701g
   PubMed Web of Science ®Google Scholar
• Hasnain, M.S., Rao, S., Singh, M.K., Vig, N., Budakoti, S., Singh, M. (2011). Development and validation of an improved LC-MS/MS Method for the quantification of desloratadine and its metabolite in human plasma. J. Pharm. Bioal. Sci. 8: 1341–60.
   Google Scholar
• Singh, B., Beg, S. Quality by Design in product development life cycle. (2013). Chronicle Pharmabiz. 22: 72–79.
   Google Scholar
• Singh, B., Raza, K., Beg, S. (2013). Developing “Optimized” drug products employing “Designed” experiments. Chem. Ind. Digest. 12: 1–7.
   Google Scholar
• Beg, S., Rahman, M., Panda, S.S. (2017). Pharmaceutical QbD: Omnipresence in the product development lifecycle. Eur. Pharm. Rev. 22(1): 2–8.
   Google Scholar
• Nayak, A.K., Pal, D., Pradhan, J., Hasnain, M.S. (2013). Fenugreek seed mucilage-alginate mucoadhesive of metformin HCl: Design, optimization and evaluation. Int. J. Biol. Mac. 54: 144–154. doi: 10.1016/j.ijbiomac.2012.12.008
   PubMed Web of Science ®Google Scholar
• Nayak, A.K., Kalia, S., Hasnain, M.S. (2013). Optimization of aceclofenac-loaded pectinatepoly(vinyl pyrrolidone)beads by response surface methodology. Int. J. Biol. Mac. 62: 194–202. doi: 10.1016/j.ijbiomac.2013.08.043
   PubMed Web of Science ®Google Scholar
• Nayak, A.K., Khatua, S., Hasnain, M.S., Sen, K.K. (2011). Development of diclofenac sodium-loaded alginate-PVP K 30 microbeads using central composite design. Daru. 19(5): 356–366.
   PubMed Web of Science ®Google Scholar
• Beg, S., Kohli, K., Swain, S., Hasnain, M.S. (2012). Development and validation of RP-HPLC method for quantitation of amoxicillin trihydrate in bulk and pharmaceutical formulation using Box-Behnken experimental design. J. Liq. Chromat. Rel. Tech. 35: 393–406. doi: 10.1080/10826076.2011.601493
   Web of Science ®Google Scholar
• Beg, S., Sharma, G., Katare, O.P., Lohan, S., Singh, B. (2015). Development and validation of a stability-indicating liquid chromatographic method for estimating olmesartan medoxomil using Quality by Design. J. Chromat. Sci. 53(7): 1048–59. doi: 10.1093/chromsci/bmu165
   PubMed Web of Science ®Google Scholar
• Beg, S., Hasnain, M.S., Swain, S., Kohli, K. (2011). Validated stability indicating LC method for estimation of amoxicillin trihydrate in pharmaceutical dosage forms and time-dependent release formulation. Int. J. Pharm. Sci. Nanotech. 4(2): 1423–1427.
   Google Scholar
• Hasnain, M.S., Siddiqui, S., Rao, S., Mohanty, P., Ara, T.J., Beg, S. (2016). QbD-Driven Development and Validation of a Bioanalytical LC-MS Method for Quantification of Fluoxetine in Human Plasma. J. Chromat. Sci. 54(5): 736–743. doi: 10.1093/chromsci/bmv248
   PubMed Web of Science ®Google Scholar
• Hasnain, M.S., Ansari, S.A., Rao, S., Tabish, M., Singh, M., Syafiq, S., Ansari, M.T. (2017). QbD-Driven Development and Validation of a Bioanalytical LC-MS Method for Quantification of Sildenafil in Human Plasma. J. Chrom. Sci. 55(6): 587–594. doi: 10.1093/chromsci/bmx010
   PubMed Web of Science ®Google Scholar
• Beg, S., Jain, A., Kaur, R., Panda, S.S., Katare, O.P., Singh, B. (2016). QbD-driven development and validation of an efficient bioanalytical UPLC method for estimation of olmesartan medoxomil. J. Liq. Chromatograph. Rel. Technol. 39: 587–97. doi: 10.1080/10826076.2016.1206023
   Web of Science ®Google Scholar
• Beg, S., Chaudhary, V., Sharma, G., Garg, B., Panda, S.S., Singh, B. (2016). QbD-oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid-liquid extraction and chromatographic separation. Biomed. Chromatograph. 30: 818–828. doi: 10.1002/bmc.3613
   PubMed Web of Science ®Google Scholar
• Beg, S., Panda, S.S., Katare, O.P., Singh, B. (2017). Applications of monte-carlo simulation and chemometric techniques for development of bioanalytical liquid chromatography method for estimation of rosuvastatin calcium. J. Liq. Chromatograph. Rel. Technol. 40(18): 907–920. doi: 10.1080/10826076.2017.1382377
   Web of Science ®Google Scholar