Development of a validated bioanalytical method for the simultaneous estimation of ornidazole and miconazole in rat plasma by LC-MS/MS and its application to a pharmacokinetic study

References

• Itriyeva, K. Evaluation of Vulvovaginitis in the Adolescent Patient. Curr. Probl. Pediatr. Adolesc. Health Care 2020, 50, 100836. DOI: 10.1016/j.cppeds.2020.100836.
   PubMed Web of Science ®Google Scholar
• Angotti, L. B.; Lambert, L. C.; Soper, D. E. Vaginitis: Making Sense of over-the-Counter Treatment Options Infect. Infect. Dis. Obstet. Gynecol. 2007, 2007, 97424. DOI: 10.1155/2007/97424.
   PubMedGoogle Scholar
• Powell, A. M.; Sarria, I.; Goje, O. Microbiome and Vulvovaginitis. Obstet Gynecol. Clin. North Am. 2023, 50, 311–326. DOI: 10.1016/j.ogc.2023.02.005.
   PubMed Web of Science ®Google Scholar
• Arechavala, A.; Negroni, R.; Santiso, G.; Depardo, R.; Bonvehí, P. Chronic Recurrent Vulvovaginitis is Not Only Due to Candida. Rev. Iberoam. Micol. 2021, 38, 132–137. DOI: 10.1016/j.riam.2021.03.002.
   PubMed Web of Science ®Google Scholar
• Sobel, J. D.; Brooker, D.; Stein, G. E.; Thomason, J. L.; Wermeling, D. P.; Bradley, B.; Weinstein, L. Single Oral Dose Fluconazole Compared with Conventional Clotrimazole Topical Therapy of Candida Vaginitis. Fluconazole Vaginitis Study Group. Am. J. Obstet. Gynecol. 1995, 172, 1263–1268. DOI: 10.1016/0002-9378(95)91490-0.
   PubMed Web of Science ®Google Scholar
• Cronly, M.; Behan, P.; Foley, B.; Malone, E.; Regan, L. Development and Validation of a Rapid Method for the Determination and Confirmation of 10 Nitroimidazoles in Animal Plasma Using Liquid Chromatography Tandem Mass Spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2009, 877, 1494–1500. DOI: 10.1016/j.jchromb.2009.03.030.
   PubMed Web of Science ®Google Scholar
• Kauffman, C. A.; Carver, P. L. Use of Azoles for Systemic Antifungal Therapy. Adv. Pharmacol. 1997, 39, 143–189. DOI: 10.1016/s1054-3589(08)60071-x.
   PubMedGoogle Scholar
• Kjærstad, M. B.; Nielsen, F.; Nøhr-Jensen, L.; Zwisler, S.; Brøsen, K.; Andersen, H. R. Systemic Uptake of Miconazole during Vaginal Suppository Use and Effect on CYP1A2 and CYP3A4 Associated Enzyme Activities in Women. Eur. J. Clin. Pharmacol. 2010, 66, 1189–1197. DOI: 10.1007/s00228-010-0906-2.
   PubMed Web of Science ®Google Scholar
• Bakshi, M.; Singh, B.; Singh, A.; Singh, S, International Conference on Harmonization. The ICH Guidance in Practice: stress Degradation Studies on Ornidazole and Development of a Validated Stability-Indicating Assay. J. Pharm. Biomed. Anal. 2001, 26, 891–897. DOI: 10.1016/s0731-7085(01)00475-7.
   PubMed Web of Science ®Google Scholar
• Sudhakar, M.; Venkateshwara, R.; Devika, G.; Ramesh, P. R. A Validated RP-HPLC Method for Simultaneous Estimation of Cefixime Trihydrate and Ornidazole in Tablet Dosage Forms. Int. J. Chem. Pharm. Sci. 2010, 1, 34–39.
   Google Scholar
• Natarajan, S.; Raman, B. Development and Validation of a Stability-Indicating HPLC Method for Simultaneous Estimation of Ofloxacin and Ornidazole. Indian Pharmacist. 2005, 4, 79–84.
   Google Scholar
• Patel, S. A.; Prajapati, A. M.; Patel, P. U.; Patel, N. J.; Vaghmasi, J. B. Development and Validation of Column High-Performance Liquid Chromatographic and Derivative Spectrophotometric Methods for Determination of Levofloxacin and Ornidazole in Combined Dosage Forms. J. AOAC Int. 2008, 91, 756–761.
   PubMed Web of Science ®Google Scholar
• Pande, V.; Chandorkar, J. G. A Sensitive HPLC Method of Determination of 2-Methyl 5-Nitroimidazole & Reaction Mass of Intermediates of Ornidazole in Ornidazole Bulk Manufacturing. Int. J. Pharmtech. Res. 2009, 1, 310–312.
   Google Scholar
• Solomon, W. S.; Gowda, K. V.; Selvan, P. S.; Mandal, U.; Pal, T. K. HPLC Method for Quantification of Ornidazole in Human Plasma. Asian J. Chem. 2008, 20, 4361.
   Google Scholar
• Du, J.; Deng, P.; Chen, X.; Wang, H.; You, T.; Zhong, D. Characterization of Ornidazole Metabolites in Human Bile after Intraveneous Doses by Ultraperformance Liquid Chromatography/Quadrupole Time-of-Flight Mass Spectrometry. Acta Pharm. Sin. B 2012, 2, 159–167. DOI: 10.1016/j.apsb.2012.01.002.
   Google Scholar
• Du, J.; Ma, Z.; Zhang, Y.; Wang, T.; Chen, X.; Zhong, D. Simultaneous Determination of Ornidazole and Its Main Metabolites in Human Plasma by LC–MS/MS: application to a Pharmacokinetic Study. Bioanalysis 2014, 6, 2343–2356. DOI: 10.4155/bio.14.117.
   PubMed Web of Science ®Google Scholar
• Cronly, M.; Behan, P.; Foley, B.; Malone, E.; Regan, L. Rapid Confirmatory Method for the Determination of 11 Nitroimidazoles in Egg Using Liquid Chromatography Tandem Mass Spectrometry. J. Chromatogr. A 2009, 1216, 8101–8109. DOI: 10.1016/j.chroma.2009.04.074.
   PubMed Web of Science ®Google Scholar
• Sun, H.-W.; Wang, F.-C.; Ai, L.-F. Simultaneous Determination of Seven Nitroimidazole Residues in Meat by Using HPLC-UV Detection with Solid-Phase Extraction. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2007, 857, 296–300. DOI: 10.1016/j.jchromb.2007.07.039.
   PubMed Web of Science ®Google Scholar
• Heizmann, P.; Geschke, R.; Zinapold, K. Determination of Ornidazole and Its Main Metabolites in Biological Fluids. J. Chromatogr. 1990, 534, 233–240. DOI: 10.1016/s0378-4347(00)82168-4.
   PubMed Web of Science ®Google Scholar
• Sun, H.; Wang, F.; Ai, L.; Guo, C.; Chen, R. Validated Method for Determination of Eight Banned Nitroimidazole Residues in Natural Casings by LC/MS/MS with Solid-Phase Extraction. J. AOAC Int. 2009, 92, 612–621. DOI: 10.1093/jaoac/92.2.612.
   PubMed Web of Science ®Google Scholar
• Sharma, D.; Gupta, K.; Chawla, P. Method Development and Validation for Simultaneous Estimation of Clotrimazole, Miconazole Nitrate, and Tinidazole by Reversed-Phase High-Performance Liquid Chromatography Method in Tablets. Asian J. Pharm. Clin. Res. 2019, 12, 124–128.
   Google Scholar
• El-Bagary, R. I.; Elkady, E. F.; Tammam, M. H.; Elmaaty, A. A. Simultaneous Determination of Miconazole and Hydrocortisone or Mometasone Using Reversed Phase Liquid Chromatography. Eur. J. Chem. 2012, 3, 421–425. DOI: 10.5155/eurjchem.3.4.421-425.667.
   Google Scholar
• Heneedak, H. M.; Salama, I.; Mostafa, S.; El-Sadek, M. HPLC and Chemometric Methods for the Simultaneous Determination of Miconazole Nitrate and Nystatin. J. Chromatogr. Sci. 2012, 50, 855–861. DOI: 10.1093/chromsci/bms127.
   PubMed Web of Science ®Google Scholar
• Akay, C.; Ozkan, S. A.; Sentürk, Z.; Cevheroğlu, S. Simultaneous Determination of Metronidazole and Miconazole in Pharmaceutical Dosage Forms by RP-HPLC. Farmaco 2002, 57, 953–957. DOI: 10.1016/s0014-827x(02)01296-x.
   PubMedGoogle Scholar
• Boleda, M. R.; Galceran, M. T.; Ventura, F. Validation and Uncertainty Estimation of a Multiresidue Method for Pharmaceuticals in Surface and Treated Waters by Liquid Chromatography–Tandem Mass Spectrometry. J. Chromatogr. A 2013, 1286, 146–158. DOI: 10.1016/j.chroma.2013.02.077.
   PubMed Web of Science ®Google Scholar
• Van De Steene, J. C.; Lambert, W. E. Validation of a Solid-Phase Extraction and Liquid Chromatography–Electrospray Tandem Mass Spectrometric Method for the Determination of Nine Basic Pharmaceuticals in Wastewater and Surface Water Samples. J. Chromatogr. A 2008, 1182, 153–160. DOI: 10.1016/j.chroma.2008.01.012.
   PubMed Web of Science ®Google Scholar
• Van De Steene, J. C.; Mortier, K. A.; Lambert, W. E. Tackling Matrix Effects during Development of a Liquid Chromatographic–Electrospray Ionisation Tandem Mass Spectrometric Analysis of Nine Basic Pharmaceuticals in Aqueous Environmental Samples. J. Chromatogr. A 2006, 1123, 71–81. DOI: 10.1016/j.chroma.2006.05.013.
   PubMed Web of Science ®Google Scholar
• Van De Steene, J. C.; Stove, C. P.; Lambert, W. E. A Field Study on 8 Pharmaceuticals and 1 Pesticide in Belgium: removal Rates in Waste Water Treatment Plants and Occurrence in Surface Water. Sci. Total Environ. 2010, 408, 3448–3453. DOI: 10.1016/j.scitotenv.2010.04.037.
   PubMed Web of Science ®Google Scholar
• Turner, A.; Warnock, D. W. Determination of Miconazole in Human Saliva’using High-Performance Liquid Chromatography. J. Chromatogr. 1982, 227, 229–232. DOI: 10.1016/s0378-4347(00)80377-1.
   PubMed Web of Science ®Google Scholar
• Yu, Y.; Zhang, J.; Shao, B.; Wu, Y.; Duan, H.; Liu, H. Development of a Simple Liquid Chromatography-Tandem Mass Spectrometry Method for Multiresidue Determination of Antifungal Drugs in Chicken Tissues. J. AOAC Int. 2011, 94, 1650–1658. DOI: 10.5740/jaoacint.10-244.
   PubMedGoogle Scholar
• Chiap, P.; Hubert, P.; Crommen, J. Strategy for the Development of Automated Methods Involving Dialysis and Trace Enrichment as on-Line Sample Preparation for the Determination of Basic Drugs in Plasma by Liquid Chromatography. J. Chromatogr. A 2002, 948, 151–161. DOI: 10.1016/s0021-9673(01)01318-8.
   PubMed Web of Science ®Google Scholar
• Youdim, K. A.; Lyons, R.; Payne, L.; Jones, B. C.; Saunders, K. An Automated, High-Throughput, 384 Well Cytochrome P450 Cocktail IC50 Assay Using a Rapid Resolution LC–MS/MS End-Point. J. Pharm. Biomed. Anal. 2008, 48, 92–99. DOI: 10.1016/j.jpba.2008.05.011.
   PubMed Web of Science ®Google Scholar
• Miron, D.; Lange, A.; Zimmer, A. R.; Mayorga, P.; Schapoval, E. E. HPLC-DAD for the Determination of Three Different Classes of Antifungals: method Characterization, Statistical Approach, and Application to a Permeation Study. Biomed. Chromatogr. 2014, 28, 1728–1737. DOI: 10.1002/bmc.3213.
   PubMed Web of Science ®Google Scholar
• Phatak, H.; Vaidya, V. A Rapid Gas Chromatography- Mass Spectroscopy Method for Simultaneous Quantification of Ornidazole and Miconazole from Cream Formulations: development, Validation and Application. IJPSR 2016, 7, 2976–2983.
   Google Scholar
• Solanki, N. N.; Patel, P. B. Simultaneous Estimation of Ornidazole and Miconazole in Tablet Dosage Form by Absorbance Correction Method and First Order Derivative Method. Pharma Sci. Monitor. 2016, 7, 282–294.
   Google Scholar
• Magdy, G.; Aboelkassim, E.; El-Domany, R. A.; Belal, F. Green Synthesis, Characterization, and Antimicrobial Applications of Silver Nanoparticles as Fluorescent Nanoprobes for the Spectrofluorimetric Determination of Ornidazole and Miconazole. Sci. Rep. 2022, 12, 21395. DOI: 10.1038/s41598-022-25830-x.
   PubMed Web of Science ®Google Scholar
• Ramanlal, G. N.; Patel, D. Stability Indicating Chromatographic Method Development and Validation for the Simultaneous Estimation of Miconazole and Ornidazole in Its Pharmaceutical Dosage Form by HPLC. World J. Pharm. Res. 2017, 6, 961–996.
   Google Scholar
• Das, S.; Dubey, R.; Roychowdhury, S.; Ghosh, M.; Sinha, B. N.; Kumar Pradhan, K.; Bal, T.; Muthukrishnan, V.; Seijas, J. A.; Pujarid, A. A Rapid and Sensitive Determination of Hypoxic Radiosensitizer Agent Nimorazole in Rat Plasma by LC-MS/MS and Its Application to a Pharmacokinetic Study. Biomed. Chromatogr. 2015, 29, 1575–1580. DOI: 10.1002/bmc.3461.
   PubMedGoogle Scholar
• Rudakov, O. B.; Rudakova, L. V.; Selemenev, V. F. Acetonitrile as Tops Solvent for Liquid Chromatography and Extraction. JACS 2018, 1–19. DOI: 10.24294/jacs.v1i2.883.
   Google Scholar
• Shah, V. P.; Midha, K. K.; Findlay, J. W.; Hill, H. M.; Hulse, J. D.; McGilveray, I. J.; McKay, G.; Miller, K. J.; Patnaik, R. N.; Powell, M. L.; et al. Bioanalytical Method Validation-a Revisit with a Decade of Progress. Pharm. Res. 2000, 17, 1551–1557. DOI: 10.1023/a:1007669411738.
   PubMedGoogle Scholar
• Bioanalytical Method Validation Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry (accessed Feb 05, 2024).
   Google Scholar
• Li, Y.; Kang, J.; Lee, Y.; Chung, J.-Y.; Cho, J.-Y. A Validated Simple LC-MS/MS Method for Quantifying Trimethylamine N-Oxide (TMAO) Using a Surrogate Matrix and Its Clinical Application. Transl. Clin. Pharmacol. 2021, 29, 216–225. DOI: 10.12793/tcp.2021.29.e19.
   PubMedGoogle Scholar
• Darwish, H. W.; Attwa, M. W.; Kadi, A. A. Rapid Validated Liquid Chromatographic Method Coupled with Tandem Mass Spectrometry for Quantification of Nintedanib in Human Plasma. Trop. J. Pharm Res. 2016, 15, 2467–2473. DOI: 10.4314/tjpr.v15i11.23.
   Web of Science ®Google Scholar
• Matuszewski, B. K.; Constanzer, M. L.; Chavez-Eng, C. M. Strategies for the Assessment of Matrix Effect in Quantitative Bioanalytical Methods Based on HPLC − MS/MS. Anal. Chem. 2003, 75, 3019–3030. DOI: 10.1021/ac020361s.
   PubMed Web of Science ®Google Scholar
• Nedelman, J. R.; Jia, X. An Extension of Satterth Waite’s Approximation Applied to Pharmacokinetics. J. Biopharm Stat. 1998, 8, 317–328. DOI: 10.1080/10543409808835241.
   PubMedGoogle Scholar
• Holder, D. J. Comments on Nedelman and Jia’s Extension of Satterthwaite’s Approximation Applied to Pharmacokinetics. J. Biopharm Stat. 2001, 11, 75–79. DOI: 10.1081/bip-100104199.
   PubMedGoogle Scholar