Development of a gradient method for sulfamethoxazole, trimethoprim, isoniazid, and pyridoxine hydrochloride in rabbit plasma through QbD-driven investigation.
Bioanalytical quality by design
Gradient elution
Isoniazid
Pyridoxine
Sulfamethoxazole
Trimethoprim
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
28 10 2024
28 10 2024
Historique:
received:
07
03
2024
accepted:
18
10
2024
medline:
29
10
2024
pubmed:
29
10
2024
entrez:
29
10
2024
Statut:
epublish
Résumé
The current study developed a method for quantifying four drugs-Sulfamethoxazole, Trimethoprim, Isoniazid, and Pyridoxine-in rabbit plasma. The method uses gradient liquid chromatography based on analytical quality by design. To achieve separation, a Eclip Plus C18 (250 mm × 5 mm, 4.6 µm) column with L1 packing was used, and analytes were detected at 254 nm at ambient temperature. The optimized mobile phase consisted of 50 mM potassium dihydrogen phosphate buffer (pH 6.5) and Methanol. The concentration of Methanol was 3% (0-5 min), 15% (5-15 min), 55% (15-27 min), and 3% Methanol until the end of the 30-min runtime, and the flow rate was set at 0.95 mL/min. Control Noise Experimentation was used to screen studies, revealing that flow rate, pH, and Methanol concentration significantly affected the analytical attributes. The study identified critical attributes (resolution and asymmetric factor) and developed a quality target method profile. A central composition design was used to optimize the essential parameters. The method developed for the drugs showed peaks at retention times of 6.990 min for Isoniazid, 7.880 min for Pyridoxine, 15.530 min for Sulfamethoxazole, and 26.890 min for Trimethoprim, respectively. The method was validated with linearity in the range of 10-640 ng ml
Identifiants
pubmed: 39468294
doi: 10.1038/s41598-024-77062-w
pii: 10.1038/s41598-024-77062-w
doi:
Substances chimiques
Pyridoxine
KV2JZ1BI6Z
Isoniazid
V83O1VOZ8L
Trimethoprim
AN164J8Y0X
Sulfamethoxazole
JE42381TNV
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
25806Informations de copyright
© 2024. The Author(s).
Références
del Rio, C. The global HIV epidemic: What the pathologist needs to know. Semin. Diagn. Pathol. 34, 314–317 (2017).
doi: 10.1053/j.semdp.2017.05.001
pubmed: 28566241
pmcid: 5531065
Ratnam, M. V. R. et al. CD4 cell counts and oral manifestations in HIV infected and AIDS patients. J. Oral Maxillofac. Pathol. 22 (2018).
Birmeka, M. Distribution pattern and prevalence of opportunistic infections and their possible reciprocal effects among HIV patients, Burayu Health Centers. https://doi.org/10.3855/jidc.15105
Henderson, H. I. et al. Predicting risk of multidrug-resistant enterobacterales infections among people with HIV. Open Forum Infect. Dis. 9, 487 (2022).
doi: 10.1093/ofid/ofac487
Abdoli, A., Falahi, S. & Kenarkoohi, A. COVID-19-associated opportunistic infections: A snapshot on the current reports. Clin. Exp. Med. 22, 327–346 (2022).
doi: 10.1007/s10238-021-00751-7
pubmed: 34424451
Ali, M. et al. HIV and AIDS-defining opportunistic illnesses in the state of Qatar: A cohort population-based retrospective study covering 17 years (2000–2016). Ann. Med. Surg. 78 (2022).
Madhavan, A., Sachu, A., Samuel, A. & Vasudevapanicker, J. Cryptococcal antigen prevalence in HIV patients from a tertiary care centre in South India. 14, 740–745 (2022).
Indira, P., Kumar, P. M., Shalini, S. & Vaman, K. Opportunistic infections among people living with HIV (PLHIV) with diabetes mellitus (DM) attending a tertiary care hospital in coastal city of South India. PLoS One 10, e0136280 (2015).
doi: 10.1371/journal.pone.0136280
pubmed: 26287949
pmcid: 4545828
Duff, P. Prevention of opportunistic infections in women with HIV infection. Clin. Obstet. Gynecol. 62 (2019).
Harries, A. D., Lawn, S. D., Suthar, A. B. & Granich, R. Benefits of combined preventive therapy with co-trimoxazole and isoniazid in adults living with HIV: Time to consider a fixed-dose, single tablet coformulation. Lancet. Infect. Dis. 15, 1492–1496 (2015).
doi: 10.1016/S1473-3099(15)00242-X
pubmed: 26515525
World Health Organization. WHO-PQ recommended summary of product haracteristics. 3–3 (2021).
Letang, E. et al. Minimally invasive tissue sampling: a tool to guide efforts to reduce AIDS-related mortality in resource-limited settings. Clin. Infect. Dis. Off. Publ. Infect. Dis. Soc. Am. 73, S343–S350 (2021).
doi: 10.1093/cid/ciab789
Coelho, L. E. et al. Predictors of opportunistic illnesses incidence in post combination antiretroviral therapy era in an urban cohort from Rio de Janeiro. Brazil. BMC Infect. Dis. 16, 134 (2016).
doi: 10.1186/s12879-016-1462-x
pubmed: 27001753
Cui, Y. et al. Development of an ultra fast liquid chromatography-tandem mass spectrometry method for simultaneous determination of cefazedone and etimicin in beagle dog plasma: Application to the pharmacokinetic study of the combination of cefazedone and etimicin inje. J. Chromatogr. Anal. Technol. Biomed. Life Sci. 973, 97C–103 (2014).
doi: 10.1016/j.jchromb.2014.10.018
Chiarentin, L. et al. Drilling into ‘quality by design’ approach for analytical methods. Crit. Rev. Anal. Chem. 8, 1–42. https://doi.org/10.1080/10408347.2023.2253321 (2023).
doi: 10.1080/10408347.2023.2253321
Sharma, G., Thakur, K., Raza, K. & Katare, O. P. Stability kinetics of fusidic acid: Development and validation of stability indicating analytical method by employing analytical quality by design approach in medicinal product(s). J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 1120, 113–124 (2019).
doi: 10.1016/j.jchromb.2019.05.001
Tumpa, A., Stajić, A., Jančić-Stojanović, B. & Medenica, M. Quality by design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. J. Pharm. Biomed. Anal. 134, 18–26 (2017).
doi: 10.1016/j.jpba.2016.11.010
pubmed: 27871053
Rašević, M., Malenović, A., Protić, A. & Zečević, M. Analytical method development supported by DoE-DS approach for enantioseparation of (S, S)- and (R, R)-moxifloxacin. J. Pharm. Biomed. Anal. 235, 115645 (2023).
doi: 10.1016/j.jpba.2023.115645
pubmed: 37598470
Aboelghar, S. M., Hegazy, M. A. & Wagdy, H. A. Ecofriendly bioanalytical validated RP-HPLC method for simultaneous determination of COVID-19 co-prescribed drugs employing quality by design and green chemistry. Microchem. J. 200, 110292 (2024).
doi: 10.1016/j.microc.2024.110292
Prajapati, P. B., Bagul, N. & Kalyankar, G. Implementation of DoE and risk-based enhanced analytical quality by design approach to stability-indicating RP-HPLC method for stability study of bosutinib. J. AOAC Int. 104, 1742–1753 (2021).
doi: 10.1093/jaoacint/qsab078
pubmed: 34100929
Muchakayala, S. K. et al. AQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS. Sci. Rep. 12, 19138 (2022).
doi: 10.1038/s41598-022-22998-0
pubmed: 36352016
pmcid: 9646803
Taheri, M., Bagheri, M., Moazeni-Pourasil, R. S. & Ghassempour, A. Response surface methodology based on central composite design accompanied by multivariate curve resolution to model gradient hydrophilic interaction liquid chromatography: Prediction of separation for five major opium alkaloids. J. Sep. Sci. 40, 3602–3611 (2017).
doi: 10.1002/jssc.201700416
pubmed: 28714264
Prajapati, P., Salunkhe, M., Pulusu, V. S. & Shah, S. Integrated approach of white analytical chemistry and analytical quality by design to multipurpose RP-HPLC method for synchronous estimation of multiple fixed-dose combinations of paracetamol. Chem. Africa 7, 1353–1371 (2024).
doi: 10.1007/s42250-023-00819-9
Prajapati, P., Rana, B., Pulusu, V. S. & Mishra, A. Multipurpose RP-HPLC method for simultaneous estimation of fixed-dose combinations of anti-diabetic drugs: Integrating green, economical, and robust approaches with design of experiments and white analytical chemistry. Chem. Afr. 7, 1385–1400 (2024).
doi: 10.1007/s42250-023-00835-9
Prajapati, P., Rana, B., Pulusu, V. S. & Shah, S. Method operable design region for robust RP-HPLC analysis of pioglitazone hydrochloride and teneligliptin hydrobromide hydrate: Incorporating hybrid principles of white analytical chemistry and design of experiments. Futur. J. Pharm. Sci. 9, 93 (2023).
doi: 10.1186/s43094-023-00546-5
Konduru, N., Gundla, R., Dongala, T., Katari, N. K. & Mallavarapu, R. Development and validation of liquid chromatography method for determination of Ibrutinib in finished dosage forms using quality by design approach. Sep. Sci. PLUS 5, 254–266 (2022).
doi: 10.1002/sscp.202100063
FDA, F. & D. A. Bioanalytical Method Validation Guidance. Food Drug Adm. 1043, 25 (2018).
Dalvi, A. V., Uppuluri, C. T., Bommireddy, E. P. & Ravi, P. R. Design of experiments-based RP–HPLC bioanalytical method development for estimation of Rufinamide in rat plasma and brain and its application in pharmacokinetic study. J. Chromatogr. B 1102–1103, 74–82 (2018).
doi: 10.1016/j.jchromb.2018.10.014
Yang, G., Tazoe, H. & Yamada, M. Rapid determination of 135Cs and precise 135Cs/137Cs atomic ratio in environmental samples by single-column chromatography coupled to triple-quadrupole inductively coupled plasma-mass spectrometry. Anal. Chim. Acta 908, 177–184 (2016).
doi: 10.1016/j.aca.2015.12.041
pubmed: 26826700
Hailat, M., Al-Ani, I., Hamad, M., Zakareia, Z. & Abu Dayyih, W. Development and validation of a method for quantification of favipiravir as COVID-19 management in spiked human plasma. Molecules 26 (2021).
Abdel-Moety, E. M., Rezk, M. R., Wadie, M. & Tantawy, M. A. A combined approach of green chemistry and quality-by-design for sustainable and robust analysis of two newly introduced pharmaceutical formulations treating benign prostate hyperplasia. Microchem. J. 160, 105711 (2021).
doi: 10.1016/j.microc.2020.105711
Meng, M. et al. Simultaneous quantitation of polymyxin B1, polymyxin B2 and polymyxin B1–1 in human plasma and treated human urine using solid phase extraction and liquid chromatography–tandem mass spectrometry. J. Chromatogr. B 1012–1013, 23–36 (2016).
doi: 10.1016/j.jchromb.2016.01.013
Surve, D. H. & Jindal, A. B. Development and validation of reverse-phase high-performance liquid chromatographic (RP-HPLC) method for quantification of Efavirenz in Efavirenz-Enfuvirtide co-loaded polymer-lipid hybrid nanoparticles. J. Pharm. Biomed. Anal. 175, 112765 (2019).
doi: 10.1016/j.jpba.2019.07.013
pubmed: 31349211
Alladio, E. et al. Effective validation of chromatographic analytical methods: The illustrative case of androgenic steroids. Talanta 215, 120867 (2020).
doi: 10.1016/j.talanta.2020.120867
pubmed: 32312473
Gu, H., Liu, G., Wang, J., Aubry, A. F. & Arnold, M. E. Selecting the correct weighting factors for linear and quadratic calibration curves with least-squares regression algorithm in bioanalytical LC-MS/MS assays and impacts of using incorrect weighting factors on curve stability, data quality, and assay perfo. Anal. Chem. 86, 8959–8966 (2014).
doi: 10.1021/ac5018265
pubmed: 25157966
Pant, A. et al. Quality by design-steered development and validation of analytical and bioanalytical methods for raloxifene: Application of Monte Carlo simulations and variance inflation factor. Biomed. Chromatogr. 37, e5641 (2023).
doi: 10.1002/bmc.5641
pubmed: 37041119
Abdelwahab, N. S., Ali, N. W., Zaki, M. M., Sharkawi, S. M. Z. & Abdelkawy, M. M. Simultaneous determination of thalidomide and dexamethasone in rat plasma by validated HPLC and HPTLC with pharmacokinetic study. J. Chromatogr. Sci. 57, 130–138 (2019).
doi: 10.1093/chromsci/bmy094
pubmed: 30272138
Method, B., An, V., Goch, W. & Giebułtowicz, J. Replicates number for drug stability testing during bioanalytical method validation—An experimental and retrospective approach (2022).
Patel, K. Y., Dedania, Z. R., Dedania, R. R. & Patel, U. QbD approach to HPLC method development and validation of ceftriaxone sodium 4 (2021).
Shamim, A. et al. QbD-engineered development and validation of a RP-HPLC method for simultaneous estimation of rutin and ciprofloxacin HCl in bilosomal nanoformulation. ACS Omega 8, 21618–21627 (2023).
doi: 10.1021/acsomega.3c00956
pubmed: 37360463
pmcid: 10286274
Kumari, M. & Gupta, S. K. Response surface methodological ( RSM ) approach for optimizing the removal of trihalomethanes (THMs) and its precursor’s by surfactant modified magnetic nanoadsorbents (sMNP)—An endeavor to diminish probable cancer risk 1–11. https://doi.org/10.1038/s41598-019-54902-8 (2019).
Hanafi, R. S. & Lämmerhofer, M. Response surface methodology for the determination of the design space of enantiomeric separations on cinchona-based zwitterionic chiral stationary phases by high performance liquid chromatography. J. Chromatogr. A 1534, 55–63 (2018).
doi: 10.1016/j.chroma.2017.12.044
pubmed: 29279137
Surapuraju, P. K. R. & Juturu, R. R. Development, robustness by design expert and validation of a method for enantiomeric impurity content determination in pretomanid drug substance and pharmaceutical dosage form. J. Chromatogr. Sci. https://doi.org/10.1093/chromsci/bmac090 (2022).
doi: 10.1093/chromsci/bmac090
Hassan, R. M., Saleh, O. A., El-Azzouny, A. A., Aboul-Enein, H. Y. & Fouad, M. A. Experimental design optimization of simultaneous enantiomeric separation of atenolol and chlorthalidone binary mixture by high-performance liquid chromatography using polysaccharide-based stationary phases. Chirality 33, 397–408 (2021).
doi: 10.1002/chir.23315
pubmed: 33964031
da Silva, B., Valdomiro Gonzaga, L., Fett, R. & Oliveira Costa, A. C. Simplex-centroid design and Derringer’s desirability function approach for simultaneous separation of phenolic compounds from Mimosa scabrella Bentham honeydew honeys by HPLC/DAD. J. Chromatogr. A 1585, 182–191 (2019).
doi: 10.1016/j.chroma.2018.11.072
pubmed: 30522772
Variables, R. SS symmetry on the application of a design of experiments along with an ANFIS and a desirability function to model response variables (2021).
Prajapati, P., Rana, B., Pulusu, V. S. & Shah, S. Simultaneous chromatographic estimation of vildagliptin and dapagliflozin using hybrid principles of white analytical chemistry and analytical quality by design. J. AOAC Int. 107, 212–222 (2024).
doi: 10.1093/jaoacint/qsad108
pubmed: 37698979
Salwa, & Kumar, L. Quality-by-design driven analytical method (AQbD) development and validation of HPLC–UV technique to quantify rivastigmine hydrogen tartrate in lipidic nanocarriers: Forced degradation, and assessment of drug content and in vitro release studies. Microchem. J. 193, 108944 (2023).
doi: 10.1016/j.microc.2023.108944
Ingle, R. G., Zeng, S., Jiang, H. & Fang, W.-J. Current developments of bioanalytical sample preparation techniques in pharmaceuticals. J. Pharm. Anal. 12, 517–529 (2022).
doi: 10.1016/j.jpha.2022.03.001
pubmed: 36105159
pmcid: 9463481
Eckernäs, E. et al. Development and application of a highly sensitive LC-MS/MS method for simultaneous quantification of N,N-dimethyltryptamine and two of its metabolites in human plasma. J. Pharm. Biomed. Anal. 212, 114642 (2022).
doi: 10.1016/j.jpba.2022.114642
pubmed: 35149418
Chapter 2 Fundamental strategies for bioanalytical sample preparation. in High Throughput Bioanalytical Sample Preparation (ed. Wells, D. A. B. T.-P. in P. and B. A.) vol. 5 41–74 (Elsevier, 2003).
Baldelli, S., Marrubini, G., Cattaneo, D., Clementi, E. & Cerea, M. Application of Quality by Design Approach to Bioanalysis: Development of a Method for Elvitegravir Quantification in Human Plasma. Therapeutic Drug Monitoring vol. 39 (2017).
Fares, M. Y., Hegazy, M. A., El-Sayed, G. M., Abdelrahman, M. M. & Abdelwahab, N. S. Quality by design approach for green HPLC method development for simultaneous analysis of two thalassemia drugs in biological fluid with pharmacokinetic study. RSC Adv. 12, 13896–13916 (2022).
doi: 10.1039/D2RA00966H
pubmed: 35548387
pmcid: 9084420