Supercritical Fluid Chromatography for pharmaceutical quality control: current challenges and perspectives

Supercritical fluid chromatography (SFC); Mass spectrometry (MS); Pharmaceutical quality control (QC); Good manufacturing practices (GMP); Analytical method lifecycle; Validation; Quality by Design (QbD)

Abstract :

[en] Quality control is a fundamental and critical activity in the pharmaceutical industry that permits to guarantee the quality of medicines and consequently safeguard the health of the patients. In recent years, supercritical fluid chromatography has emerged as a robust and suitable analytical technique in several fields thanks to the introduction of modern SFC instrument. The present review aims to give an overview of the recent advances of the use of SFC in pharmaceutical QC and highlights current challenges and perspectives. SFC instrumentation is presented and published applications are discussed from an analytical method lifecycle point of view. At each step regulatory requirements and recommendations are also presented to highlight the readiness of modern SFC for pharmaceutical QC.

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Jambo, Hugues ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Dispas, Amandine ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Language :

English

Title :

Supercritical Fluid Chromatography for pharmaceutical quality control: current challenges and perspectives

Publication date :

2022

Journal title :

TrAC: Trends in Analytical Chemistry

ISSN :

0165-9936

eISSN :

1879-3142

Publisher :

Elsevier, Amsterdam, Netherlands

Peer reviewed :

Peer Reviewed verified by ORBi

Name of the research project :

FAKEPHARE

Funders :

FEDER - Fonds Européen de Développement Régional [BE]

Available on ORBi :

since 02 December 2021

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Bibliography

Eudralex – volume 4 – good manufacturing practice (GMP) guidelines. https://ec.europa.eu/health/documents/eudralex/vol-4_en.
Mattrey, F.T., Makarov, A.A., Regalado, E.L., Bernardoni, F., Figus, M., Hicks, M.B., Zheng, J., Wang, L., Schafer, W., Antonucci, V., Hamilton, S.E., Zawatzky, K., Welch, C.J., Current challenges and future prospects in chromatographic method development for pharmaceutical research. Trac. Trends Anal. Chem. 95 (2017), 36–46, 10.1016/j.trac.2017.07.021.
Tarafder, A., Metamorphosis of supercritical fluid chromatography to SFC: an Overview. Trac. Trends Anal. Chem. 81 (2016), 3–10, 10.1016/j.trac.2016.01.002.
Losacco, G.L., Veuthey, J.L., Guillarme, D., Supercritical fluid chromatography – mass spectrometry: recent evolution and current trends. Trac. Trends Anal. Chem. 118 (2019), 731–738, 10.1016/j.trac.2019.07.005.
Losacco, G.L., Veuthey, J.-L., Guillarme, D., Metamorphosis of supercritical fluid chromatography: a viable tool for the analysis of polar compounds?. Trac. Trends Anal. Chem., 141, 2021, 116304, 10.1016/j.trac.2021.116304.
Berger, T.A., Evolution of instrumentation for analytical scale supercritical fluid chromatography. Supercritical Fluid Chromatography, 2017, Elsevier, 173–212, 10.1016/B978-0-12-809207-1.00007-0.
U.S. Pharmacopeia, Chapter 1058 - Analytical Instrument Qualification.
Plachká, K., Chrenková, L., Douša, M., Nováková, L., Development, validation and comparison of UHPSFC and UHPLC methods for the determination of agomelatine and its impurities. J. Pharmaceut. Biomed. Anal. 125 (2016), 376–384, 10.1016/j.jpba.2016.04.020.
Plachká, K., Khalikova, M., Babičová, B., Němcová, Z., Roubíčková, L., Svec, F., Nováková, L., Ultra-high performance supercritical fluid chromatography in impurity control II: method validation. Anal. Chim. Acta 1117 (2020), 48–59, 10.1016/j.aca.2020.04.038.
Nováková, L., Sejkorová, M., Smolková, K., Plachká, K., Švec, F., The benefits of ultra-high-performance supercritical fluid chromatography in determination of lipophilic vitamins in dietary supplements. Chromatographia 82 (2019), 477–487, 10.1007/s10337-018-3666-2.
Pandya, P.A., Shah, P.A., Shrivastav, P.S., Separation of achiral anti-diabetic drugs using sub/supercritical fluid chromatography with a polysaccharide stationary phase: thermodynamic considerations and molecular docking study. J. Pharmaceut. Biomed. Anal., 189, 2020, 113452, 10.1016/j.jpba.2020.113452.
Mazzoccanti, G., Ismail, O.H., D'Acquarica, I., Villani, C., Manzo, C., Wilcox, M., Cavazzini, A., Gasparrini, F., Cannabis through the looking glass: chemo- and enantio-selective separation of phytocannabinoids by enantioselective ultra high performance supercritical fluid chromatography. Chem. Commun. 53 (2017), 12262–12265, 10.1039/C7CC06999E.
Agrawal, R., Belemkar, S., Bonde, C., Supercritical fluid chromatography versus liquid chromatography for the enantiomeric separation of itraconazole. Microchem. J., 158, 2020, 105320, 10.1016/j.microc.2020.105320.
Feng, L., Wu, L., Guo, Y., Hamada, N., Hashi, Y., Li, X., Cao, L., Determination of vitamin D3 in daily oily supplements by a two-dimensional supercritical fluid chromatography-liquid chromatography-mass spectrometry system. J. Chromatogr. A, 1629, 2020, 461510, 10.1016/j.chroma.2020.461510.
Iguiniz, M., Corbel, E., Roques, N., Heinisch, S., On-line coupling of achiral reversed phase liquid chromatography and chiral supercritical fluid chromatography for the analysis of pharmaceutical compounds. J. Pharmaceut. Biomed. Anal. 159 (2018), 237–244, 10.1016/j.jpba.2018.06.058.
Barhate, C.L., Lopez, D.A., Makarov, A.A., Bu, X., Morris, W.J., Lekhal, A., Hartman, R., Armstrong, D.W., Regalado, E.L., Macrocyclic glycopeptide chiral selectors bonded to core-shell particles enables enantiopurity analysis of the entire verubecestat synthetic route. J. Chromatogr. A 1539 (2018), 87–92, 10.1016/j.chroma.2018.01.042.
Puppala, U., Srinivas, K.S.V., Reddy, K.V., Kaliyaperumal, M., Pakalapati, S.R., Enantiospecific UPC2 SFC-MS method for separation and quantification of R & S-Eliglustat tartrate in presence of its stereo isomers and degradation impurities. Mater. Today: Proceedings 19 (2019), 420–428, 10.1016/j.matpr.2019.07.629.
Pandya, P.A., Shah, P.A., Shrivastav, P.S., Application of supercritical fluid chromatography for separation and quantitation of 15 co-formulated binary anti-hypertensive medications using a single elution protocol. Biomed. Chromatogr., 35, 2021, 10.1002/bmc.5035.
Prajapati, P., Agrawal, Y.K., SFC-MS for the identification and estimation of ethambutol in its dosage form and in human urine samples. Anal. Methods. 8 (2016), 4895–4902, 10.1039/C6AY01208F.
Rao G, V.N., R.B., J.D., M.P., Nadh, R.V., Supercritical fluid (CO2) chromatography for quantitative determination of selected cancer therapeutic drugs in the prescence of potential impurities in injection formulations. Anal. Methods. 9 (2017), 3003–3018, 10.1039/C7AY00779E.
Hicks, M.B., Regalado, E.L., Tan, F., Gong, X., Welch, C.J., Supercritical fluid chromatography for GMP analysis in support of pharmaceutical development and manufacturing activities. J. Pharmaceut. Biomed. Anal. 117 (2016), 316–324, 10.1016/j.jpba.2015.09.014.
Deidda, R., Schelling, C., Roussel, J., Dispas, A., De Bleye, C., Ziemons, É., Hubert, P., Veuthey, J., The analysis of cannabinoids in cannabis samples by supercritical fluid chromatography and ultra-high performance liquid chromatography: a comparison study. Analytical Science Advances, 2020, 1–13, 10.1002/ansa.202000091.
Hofstetter, R.K., Potlitz, F., Schulig, L., Kim, S., Hasan, M., Link, A., Subcritical fluid chromatography at sub-ambient temperatures for the chiral resolution of ketamine metabolites with rapid-onset antidepressant effects. Molecules, 24, 2019, 1927, 10.3390/molecules24101927.
Pandya, P.A., Shah, P.A., Shrivastav, P.S., Analytical separation of four stereoisomers of luliconazole using supercritical fluid chromatography: thermodynamic aspects and simulation study with chiral stationary phase. J. Chromatogr. A, 1625, 2020, 461299, 10.1016/j.chroma.2020.461299.
Andri, B., Lebrun, P., Dispas, A., Klinkenberg, R., Streel, B., Ziemons, E., Marini, R.D., Hubert, P., Optimization and validation of a fast supercritical fluid chromatography method for the quantitative determination of vitamin D3 and its related impurities. J. Chromatogr. A 1491 (2017), 171–181, 10.1016/j.chroma.2017.01.090.
Andri, B., Dispas, A., Klinkenberg, R., Streel, B., Marini, R.D., Ziémons, E., Hubert, Ph, Is supercritical fluid chromatography hyphenated to mass spectrometry suitable for the quality control of vitamin D3 oily formulations?. J. Chromatogr. A 1515 (2017), 209–217, 10.1016/J.CHROMA.2017.07.057.
Schmidtsdorff, S., Schmidt, A.H., Simultaneous detection of nitrosamines and other sartan-related impurities in active pharmaceutical ingredients by supercritical fluid chromatography. J. Pharmaceut. Biomed. Anal. 174 (2019), 151–160, 10.1016/j.jpba.2019.04.049.
Schmidtsdorff, S., Neumann, J., Schmidt, A.H., Parr, M.K., Analytical lifecycle management for comprehensive and universal nitrosamine analysis in various pharmaceutical formulations by supercritical fluid chromatography. J. Pharmaceut. Biomed. Anal., 197, 2021, 113960, 10.1016/j.jpba.2021.113960.
Dispas, A., Desfontaine, V., Andri, B., Lebrun, P., Kotoni, D., Clarke, A., Guillarme, D., Hubert, P., Quantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography. J. Pharmaceut. Biomed. Anal. 134 (2017), 170–180, 10.1016/j.jpba.2016.11.039.
Dispas, A., Marini, R., Desfontaine, V., Veuthey, J.-L., Kotoni, D., Gioacchino Losacco, L., Clarke, A., Muscat Galea, C., Mangelings, D., Jocher, B.M., Regalado, E.L., Plachká, K., Nováková, L., Wuyts, B., Franç ois, I., Gray, M., Aubin, A.J., Tarafder, A., Cazes, M., Desvignes, C., Villemet, L., Sarrut, M., Raimbault, A., Lemasson, E., Lesellier, E., West, C., Leek, T., Wong, M., Dai, L., Zhang, K., Grand-Guillaume Perrenoud, A., Brunelli, C., Hennig, P., Bertin, S., Mauge, F., Da Costa, N., Farrell, W.P., Hill, M., Desphande, N., Grangrade, M., Sadaphule, S., Yadav, R., Rane, S., Shringare, S., Iguiniz, M., Heinisch, S., Lefevre, J., Corbel, E., Roques, N., Vander Heyden, Y., Guillarme, D., Hubert, P., First inter-laboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities. J. Pharmaceut. Biomed. Anal. 161 (2018), 414–424, 10.1016/j.jpba.2018.08.042.
Dispas, A., Clarke, A., Perrenoud, A.G.-G., Losacco, L.G., Veuthey, J.-L., Gros, Q., Molineau, J., Noireau, A., West, C., Salafia, F., Zoccali, M., Mondello, L., Guillen, A., Wang, J., Zhang, K., Jochems, P., Schad, G., Nakajima, K., Horie, S., Joseph, J., Parr, M.K., Billemont, P., Severino, A., Schneider, S., Naegele, E., Kutscher, D., Wikfors, R., Black, R., Ingvaldson, L., Da Silva, J.O., Bennett, R., Regalado, E.L., Hoang, T.P.T., Touboul, D., Nikolova, Y., Kamenova-Nacheva, M., Dimitrov, V., Berger, B.K., Schug, K.A., Kerviel-Guillon, S., Mauge, F., Takahashi, M., Izumi, Y., Bamba, T., Rouvière, F., Heinisch, S., Guillarme, D., Hubert, P., Interlaboratory study of a Supercritical Fluid Chromatography method for the determination of pharmaceutical impurities: evaluation of multi-systems reproducibility. J. Pharmaceut. Biomed. Anal., 2021, 114206, 10.1016/j.jpba.2021.114206.
Jambo, H., Dispas, A., Avohou, H.T., André, S., Hubert, C., Lebrun, P., Ziemons, É., Hubert, P., Implementation of a generic SFC-MS method for the quality control of potentially counterfeited medicinal cannabis with synthetic cannabinoids. J. Chromatogr. B 1092 (2018), 332–342, 10.1016/j.jchromb.2018.05.049.
Petruševska, V., Krtalić, I., Rašić, A., Mornar, A., Development of a robust SFC method for evaluation of compatibility for a novel antituberculotic fixed-dose combination. Anal. Methods. 11 (2019), 1777–1787, 10.1039/C9AY00117D.
Dispas, A., Lebrun, P., Sacré, P.Y., Hubert, P., Screening study of SFC critical method parameters for the determination of pharmaceutical compounds. J. Pharmaceut. Biomed. Anal. 125 (2016), 339–354, 10.1016/j.jpba.2016.04.005.
Santana, I.M., Jardim, I.C.S.F., Breitkreitz, M.C., Sequential design of experiments approach for the multiproduct analysis of cholesterol-lowering drugs by ultra-high-performance supercritical fluid chromatography. J. Separ. Sci. 43 (2020), 4234–4242, 10.1002/jssc.202000702.
Kurmi, M., Jayaraman, K., Natarajan, S., Kumar, G.S., Bhutani, H., Bajpai, L., Rapid and efficient chiral method development for lamivudine and tenofovir disoproxil fumarate fixed dose combination using ultra-high performance supercritical fluid chromatography: a design of experiment approach. J. Chromatogr. A, 1625, 2020, 461257, 10.1016/j.chroma.2020.461257.
Muscat Galea, C., Didion, D., Clicq, D., Mangelings, D., Vander Heyden, Y., Method optimization for drug impurity profiling in supercritical fluid chromatography: application to a pharmaceutical mixture. J. Chromatogr. A 1526 (2017), 128–136, 10.1016/j.chroma.2017.10.036.
Bouchot, P., Foulon, C., Lecoeur, M., Determination of the stoichiometry between a drug and its counter-ion by supercritical fluid chromatography using ultra-violet and evaporative light scattering detections: application to ondansetron hydrochloride. Talanta, 218, 2020, 121166, 10.1016/j.talanta.2020.121166.
Regalado, E.L., Welch, C.J., Separation of achiral analytes using supercritical fluid chromatography with chiral stationary phases. Trac. Trends Anal. Chem. 67 (2015), 74–81, 10.1016/j.trac.2015.01.004.
Plachká, K., Švec, F., Nováková, L., Ultra-high performance supercritical fluid chromatography in impurity control: searching for generic screening approach. Anal. Chim. Acta 1039 (2018), 149–161, 10.1016/j.aca.2018.07.008.
Vander Heyden, Y., Nijhuis, A., Smeyers-Verbeke, J., Vandeginste, B.G.M., Massart, D.L., Guidance for robustness/ruggedness tests in method validation. J. Pharmaceut. Biomed. Anal. 24 (2001), 723–753, 10.1016/S0731-7085(00)00529-X.
Parr, M.K., Schmidt, A.H., Life cycle management of analytical methods. J. Pharmaceut. Biomed. Anal. 147 (2018), 506–517, 10.1016/j.jpba.2017.06.020.
ICH Q8 (R2). Pharmaceutical Development. 2009.
ICH Q9. Quality Risk Management. 2005.
ICH Q10. Pharmaceutical Quality System. 2008.
Pohl, M., Smith, K., Schweitzer, M., Hanna-Brown, M., Larew, J., Hansen, G., Borman, P., Nethercote, P., Implications and opportunities of applying QbD principles to analytical measurements. Pharmaceut. Technol. 34 (2010), 52–59.
Deidda, R., Orlandini, S., Hubert, P., Hubert, C., Risk-based approach for method development in pharmaceutical quality control context: a critical review. J. Pharmaceut. Biomed. Anal. 161 (2018), 110–121, 10.1016/j.jpba.2018.07.050.
Dispas, A., Avohou, H.T., Lebrun, P., Hubert, P., Hubert, C., ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances. Trac. Trends Anal. Chem. 101 (2018), 24–33, 10.1016/j.trac.2017.10.028.
Peraman, R., Bhadraya, K., Padmanabha Reddy, Y., Analytical quality by design: a tool for regulatory flexibility and robust analytics. International Journal of Analytical Chemistry, 2015, 1–9, 10.1155/2015/868727.
Bouabidi, A., Rozet, E., Fillet, M., Ziemons, E., Chapuzet, E., Mertens, B., Klinkenberg, R., Ceccato, A., Talbi, M., Streel, B., Bouklouze, A., Boulanger, B., Hubert, P., Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept. J. Chromatogr. A 1217 (2010), 3180–3192, 10.1016/j.chroma.2009.08.051.
ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology. 2005.
Dispas, A., Lebrun, P., Hubert, P., Validation of supercritical fluid chromatography methods. Supercritical Fluid Chromatography, 2017, Elsevier, 317–344, 10.1016/B978-0-12-809207-1.00011-2.
Hubert, Ph, Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal—part I. J. Pharmaceut. Biomed. Anal. 36 (2004), 579–586, 10.1016/J.JPBA.2004.07.027.
Hubert, Ph, Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., Rozet, E., Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal – Part II. J. Pharmaceut. Biomed. Anal. 45 (2007), 70–81, 10.1016/J.JPBA.2007.06.013.
Hubert, Ph, Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., Rozet, E., Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal–Part III. J. Pharmaceut. Biomed. Anal. 45 (2007), 82–96, 10.1016/J.JPBA.2007.06.032.
Hubert, Ph, Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., Rozet, E., Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal: Part IV. Examples of application. J. Pharmaceut. Biomed. Anal. 48 (2008), 760–771, 10.1016/J.JPBA.2008.07.018.
Khalikova, M.A., Lesellier, E., Chapuzet, E., Šatínský, D., West, C., Development and validation of ultra-high performance supercritical fluid chromatography method for quantitative determination of nine sunscreens in cosmetic samples. Anal. Chim. Acta 1034 (2018), 184–194, 10.1016/j.aca.2018.06.013.
Foulon, C., Di Giulio, P., Lecoeur, M., Simultaneous determination of inorganic anions and cations by supercritical fluid chromatography using evaporative light scattering detection. J. Chromatogr. A 1534 (2018), 139–149, 10.1016/j.chroma.2017.12.047.
Molineau, J., Hideux, M., West, C., Chromatographic analysis of biomolecules with pressurized carbon dioxide mobile phases – a review. J. Pharmaceut. Biomed. Anal., 193, 2020, 113736, 10.1016/j.jpba.2020.113736.