Stability Studies of Rifampicin in Plasma and Urine of Tuberculosis Patients According to the European Medicines Agency Guidelines

References

• Seth SD , VimeleshS. Anti-TB drugs and drugs for mycobacterium avium complex. Textbook of Pharmacology (3rd edition).Reed Elsevier Privated Limited, New Delhi, India (2008).
   Google Scholar
• Firdaus R . RIF – an overview. Int. J. Res. Pharm. Chem.3(1), 83–87 (2013).
   Google Scholar
• Shihoo CJ , ShahSA, RathodISet al. Stability of RIF in dissolution medium in presence of isonizid. Int. J. Pharm.190(1), 109–123 (1999).
   PubMedGoogle Scholar
• Konard P , StenbergP. Rifampicin quinone is an immunosuppressant, but not RIF itself. Clin. Immunol. Immunopathol.46(1), 162–166 (1988).
   PubMedGoogle Scholar
• WHO. TB is (TB) – global TB report (2018). https://www.who.int/tb/publications/global_report/en/
   Google Scholar
• Alimuddin Z , PayamN, StewartTC. Advance in the development of new TB drug and treatment regimens. Nat. Rev. Drug. Discov.12(5), 388–408 (2013).
   PubMed Web of Science ®Google Scholar
• Patrick J , YoungB. Handbook of anti-TB agents. Tuberulosis88(2), 85–170 (2008).
   PubMed Web of Science ®Google Scholar
• Yew WW . Clinically significant interactions with drugs used in the treatment of TB. Drug Saf.25(2), 111–133 (2002).
   PubMed Web of Science ®Google Scholar
• Addington WW . The side effects and interaction of anti-TB drugs. Chest76, 782–784 (1979).
   PubMed Web of Science ®Google Scholar
• Kwara A , CaoL, YangHet al. Factors associated with variability in rifampin plasma pharmacokinetics and the relationship between rifampin concentrations and efavirenz clearance. Pharmacotherapy34(3), 265–271 (2014).
   PubMed Web of Science ®Google Scholar
• Kumar AKH , ChandrasekaranV, KannanT, LavanjaJ, SwaminathanS, RamachandranG. Intrapatient variability in plasma rifampicin & isoniazid in tuberculosis patients. Indian J. Med. Res.147(3), 287–292 (2018).
   PubMedGoogle Scholar
• Shankar BR , RajeshR, RamyaK. Method development and validation of RIF bulk and marketed capsule by simple UV-spectrophotometric analysis. AJPAMC4(1), 8–13 (2016).
   Google Scholar
• Divakar TE , SunithaS, DeepthiGK, BenjaminT, PrasadBN, FeliceCS. Assay of RIF in bulk and its dosage forms by visible spectrophotometry using chloranilic acid. ijCEPr3(1), 64–67 (2012).
   Google Scholar
• Mishra P , DurgbanshiA, PawarRP. Screening of antituberculosis drugs by thin layer chromatography. Asian J. Chem.29(7), 1583–1586 (2017).
   Google Scholar
• Shewiyo DH , KaaleE, RishaPG, DejaegherB, VerbekeJ, HeydenYV. Optimization of a reversed-phase-high-performance thin-layer chromatography method for the separation of isoniazid, ethambutol, RIF and pyrazinamide in fixed-dose combination anti-TB tablets. J. Chromatogr. A1260, 232–238 (2012).
   PubMed Web of Science ®Google Scholar
• Ali J , AliN, SultanaY, BabootaS, FaiyazS. Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs. Acta Chromatographica18, 168–179 (2007).
   Web of Science ®Google Scholar
• Goutal S , AuvityS, LegrandTet al. Validation of a simple HPLC-UV method for RIF determination in plasma: application to the study of RIF arteriovenous concentration gradient. J. Pharm. Biomed. Anal.123(10), 173–178 (2016).
   PubMedGoogle Scholar
• Glass BD , KustrinSA, ChenYJ, WischMH. Optimization of a stability-indicating HPLC method for the simultaneous determination of rif, isoniazid, and pyrazinamide in a fixed-dose combination using artificial neural networks. J. Chromatogr. Sci.45(1), 38–44 (2007).
   PubMed Web of Science ®Google Scholar
• Kumar KH , ChandraI, GeethaR, ChelviKS, LalithaV, PremaG. A validated high-performance liquid chromatography method for the determination of RIF and desacetyl RIF in plasma and urine. Indian J. Pharmacol.36(4), 231–233 (2004).
   Google Scholar
• Duraimuthumani G , KarthickSP. A high performance liquid chromatographic assay of rifampin in plasma of non-HIV-infected TB patients. IJCRCPS2(1), 90–98 (2014).
   Google Scholar
• Louveau B , FernandezC, ZahrNet al. Determination of rifampicin in human plasma by high-performance liquid chromatography coupled with ultraviolet detection after automatized solid–liquid extraction. Biomed. Chromatogr.30(12), 2009–2015 (2016).
   PubMed Web of Science ®Google Scholar
• Goutal S , AuvityS, LegrandTet al. Validation of a simple HPLC-UV method for rifampicin determination in plasma: application to the study of rifampicin arteriovenous concentration gradient. J. Pharm. Biomed. Anal.123, 173–178 (2016).
   PubMed Web of Science ®Google Scholar
• Prasanthi B , RatnaJV, PhaniRSC. Development and validation of RP-HPLC method for simultaneous estimation of rifampicin, isoniazid and pyrazinamide in human plasma. J. Anal. Chem.70(8), 1015–1022 (2015).
   Web of Science ®Google Scholar
• Pynnönen ST , TuhkanenTA. Simultaneous detection of three antiviral and four antibiotic compounds in source-separated urine with liquid chromatography. J. Sep. Sci.37(3), 219–227 (2014).
   PubMed Web of Science ®Google Scholar
• Yan H , ZhouY, XieQet al. Simultaneous analysis of isoniazid and rifampicin by high-performance liquid chromatography with gradient elution and wall-jet/thin-layer electrochemical detection. Anal. Methods6(5), 1530–1537 (2014).
   Web of Science ®Google Scholar
• Espinosa-Mansilla A , Acedo-ValenzuelaMI, MuñozDe La Peña A, CañadaCañada F, SalinasLópez F. Determination of antitubercular drugs in urine and pharmaceuticals by LC using a gradient flow combined with programmed diode array photometric detection. Talanta58(2), 273–280 (2002).
   PubMed Web of Science ®Google Scholar
• Baietto L , D’AvolioA, DeRosa FGet al. Simultaneous quantification of linezolid, rifampicin, levofloxacin, and moxifloxacin in human plasma using high-performance liquid chromatography with UV. Ther. Drug Monit.31(1), 104–109 (2009).
   PubMed Web of Science ®Google Scholar
• Marcellos LF , FariaAF, de SouzaMVNet al. Simultaneous analysis of first-line anti-TB drugs in tablets by UV spectrophotometry compared to capillary zone electrophoresis. Cent. Eur. J. Chem.10(6), 1808–1816 (2012).
   Google Scholar
• Srivastava A , WaterhouseD, ArdreyA, WardSA. Quantification of RIF in human plasma and cerebrospinal fluid by a highly sensitive and rapid liquid chromatographic–tandem mass spectrometric method. J. Pharm. Biomed. Anal.70(6), 523–528 (2012).
   PubMedGoogle Scholar
• Song SH , JunSH, ParkKUet al. Simultaneous determination of first-line anti-TB drugs and their major metabolic ratios by liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom.21(7), 1331–1338 (2007).
   PubMed Web of Science ®Google Scholar
• Hee KH , SeoJJ, LeeLS. Development and validation of liquid chromatography tandem mass spectrometry method for simultaneous quantification of first line tuberculosis drugs and metabolites in human plasma and its application in clinical study. J. Pharm. Biomed. Anal.102, 253–260 (2015).
   PubMed Web of Science ®Google Scholar
• Govender K , AdamsonJH, OwiraP. The development and validation of a LC–MS/MS method for the quantitation of metformin, rifampicin and isoniazid in rat plasma using HILIC chromatography. J. Chromatogr. B1095, 127–137 (2018).
   PubMed Web of Science ®Google Scholar
• Ranjalkar J , MathewSK, VergheseVPet al. Isoniazid and rifampicin concentrations in children with tuberculosis with either a daily or intermittent regimen: implications for the revised RNTCP 2012 doses in India. Int. J. Antimicrob. Agents51(5), 663–669 (2018).
   PubMed Web of Science ®Google Scholar
• Gao S , WangZ, XieXet al. Rapid and sensitive method for simultaneous determination of first-line anti-tuberculosis drugs in human plasma by HPLC–MS/MS: application to therapeutic drug monitoring. Tuberculosis109, 28–34 (2018).
   PubMed Web of Science ®Google Scholar
• Thakare R , GaoH, KosaREet al. Leveraging of rifampicin-dosed cynomolgus monkeys to identify bile acid 3-O-sulfate conjugates as potential novel biomarkers for organic anion-transporting polypeptides. Drug. Metab. Dispos.45(7), 721–733 (2017).
   PubMed Web of Science ®Google Scholar
• Isa F , CollinsS, LeeMHet al. Mass spectrometric identification of urinary biomarkers of pulmonary tuberculosis. EBioMedicine31, 157–165 (2018).
   PubMed Web of Science ®Google Scholar
• Prasad B , SinghS. In vitro and in vivo investigation of metabolic fate of rifampicin using an optimized sample preparation approach and modern tools of liquid chromatography–mass spectrometry. J. Pharm. Biomed. Anal.50(3), 475–490 (2009).
   PubMed Web of Science ®Google Scholar
• Esteve-Romero J , Carda-BrochS, Gil-AgustiM, Capella-PeiróME, BoseD. Micellar liquid chromatography for the determination of drug materials in pharmaceutical preparations and biological samples. Trends Analyt. Chem.24(2), 75–91 (2005).
   Web of Science ®Google Scholar
• Bose D , DurgbanshiA, Martinavarro-DominguezAet al. Rapid determination of acetaminophen in physiological fluid by liquid chromatography using SDS mobile phase and ED detection. J. Chromatogr. Sci.43(6), 313–316 (2005).
   PubMed Web of Science ®Google Scholar
• Bose D , Martinavarro-DominguezA, Gil-AgustiMet al. Therapeutic monitoring of imipramine by micellar liquid chromatography with direct injection and electrochemical detection. Biomed. Chromatogr.19(5), 343–349 (2005).
   PubMed Web of Science ®Google Scholar
• Mishra P , DurgbanshiA, PawarRP, SharmaG, BiswasP. Quality control of pyrazinamide in formulation using micellar liquid chromatography. Int. J. Pharm. Sci. Res.8(11), 4637–4644 (2017).
   Google Scholar
• Verma KK . Perspective: status and future of analytical chemistry in India. Anal. Chem.89(3), 1392–1398 (2017).
   PubMed Web of Science ®Google Scholar
• Peris-Vicente J , Casas-BrevaI, Roca-GenovésP, Esteve-RomeroJ. Application of micellar liquid chromatography for the determination of antitumoral and antiretroviral drugs in plasma. Bioanalysis6(14), 1975–1988 (2014).
   PubMed Web of Science ®Google Scholar
• Kawczak P , BączekT. Recent theoretical and practical applications of micellar liquid chromatography (MLC) in pharmaceutical and biomedical analysis. Cent. Eur. J. Chem.10(3), 570–584 (2012).
   Web of Science ®Google Scholar
• Committee for Medicinal Products for Human Use. Guidelines on bioanalytical method validation. European Medicines Agency, London, UK (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
   Google Scholar
• Torres-Lapasió JR . MICHROM Software. Micellar liquid chromatography. In:Chromatographic Science Series (Vol. 83).BerthodA, García-Álvarez-CoqueC, CazesJ ( Ed.). Marcel Dekker, New York, NY, USA (2000).
   Google Scholar
• Peris-Vicente J , Villarreal-TraverM, Casas-BrevaI, Carda-BrochS, Esteve-RomeroJ. Use of micellar liquid chromatography to analyze darunavir, ritonavir, emtricitabine, and tenofovir in plasma. J. Sep. Sci.37(20), 2825–2832 (2014).
   PubMed Web of Science ®Google Scholar
• Dubey S , ShuklaSK, DurgbanshiA, Esteve-RomeroJ, BoseD. Simultaneous determination of three traditional and two novel antiepileptic drugs using micellar liquid chromatography. Int. J. Anal. Bioanal. Chem.3(1), 1–8 (2013).
   Google Scholar
• Berthod A , García-Álvarez-CoqueC. Micellar liquid chromatography. In:Chromatographic Science Series (Vol. 83).CazesJ ( Ed.). Marcel Dekker, NY, USA (2000).
   Google Scholar
• Esteve-Romero J , Albiol-ChivaJ, Peris-VicenteJ, Ochoa-ArandaE. Development and validation of a miceller liquid chromatographic method to determine three antitumorals in plasma. Bioanalysis9(10), 799–812 (2017).
   PubMed Web of Science ®Google Scholar