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Abstract
Ultra Performance Liquid Chromatography (UPLC) is an analytical separation that maintains the practicality and principles of High-Performance Liquid Chromatography (HPLC) by increasing analysis speed, sensitivity, and resolution. The methods used for the identification of ephedrine and pseudoephedrine have been carried out using HPLC according to MA PPOMN 07/NA/2010 from the National Quality Laboratory of Drug and Food (NQCLDF). The aim of the study was to assess the superiority of the UPLC method compared to HPLC in the evaluation of ephedrine and pseudoephedrine solid dosage forms. UPLC used UPLC Waters with PDA detector at wavelength 210 nm, Aqquity column UPLC® BEH C18 (50 x 2.1 mm) with particle size 1.7 μm, mobile phase of sodium lauryl sulfate solution 25 mM and acetonitrile (60:40), flow rate 0.3 ml/min, injection volume 1 μL. Comparative parameters used in the validation of ephedrine and pseudoephedrine compounds by UPLC and HPLC methods are specificity and selectivity. The validation of the UPLC method shows the retention time for ephedrine and pseudoephedrine at minutes 3,288 and 3,048 with an RSD retention time of 0.3% and an area of 0.5%. The resolution between ephedrine and pseudoephedrine was 1.9. The length of analysis time is 27 minutes on HPLC and 6 minutes on UPLC. Based on the results of this study, the UPLC method can be used as an alternative to determine ephedrine and pseudoephedrine in solid preparations with the advantages of faster, better resolution, fewer mobile phase, reference standard and samples and shorter workload than HPLC
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References
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- Gray, N. et al. (2013) ‘Comparison of reversed-phase and hydrophilic interaction liquid chromatography for the quantification of ephedrines using medium-resolution accurate mass spectrometry’, Journal of Chromatography A, 1289, pp. 37–46. doi: https://doi.org/10.1016/j.chroma.2013.03.021.
- Heaton, J. et al. (2012) ‘Comparison of reversed-phase and hydrophilic interaction liquid chromatography for the separation of ephedrines’, Journal of Chromatography A, 1228, pp. 329–337. doi: https://doi.org/10.1016/j.chroma.2011.09.026.
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- Miranda, L. F. C., Domingues, D. S. and Queiroz, M. E. C. (2016) ‘Selective solid-phase extraction using molecularly imprinted polymers for analysis of venlafaxine, O-desmethylvenlafaxine, and N-desmethylvenlafaxine in plasma samples by liquid chromatography–tandem mass spectrometry’, Journal of Chromatography A, 1458, pp. 46–53. doi: https://doi.org/10.1016/j.chroma.2016.06.024.
- Mohamed, D. et al. (2019) ‘UPLC-MS/MS estimation of paracetamol, pseudoephedrine hydrochloride and brompheniramine maleate in plasma: Application to a pharmacokinetic study on healthy Egyptian volunteers based on ethnic difference’, Microchemical Journal, 150, p. 104146. doi: 10.1016/j.microc.2019.104146.
- Nahar, L., Onder, A. and Sarker, S. D. (2020) ‘A review on the recent advances in HPLC, UHPLC and UPLC analyses of naturally occurring cannabinoids (2010–2019)’, Phytochemical Analysis, 31(4), pp. 413–457. doi: 10.1002/pca.2906.
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- PPOMN (2010) ‘Identifikasi Efedrin dan Pseudoefedrin dalam Sediaan Padat 07/NA/10’, in Metode Analisis untuk Pengujian Obat dan Makanan di Lingkungan BPOM. Jakarta, pp. 10–15.
- Roge, A. B. et al. (2011) ‘Novel achievement of HPLC: UPLC’, International Journal of PharmTech Research, 3(3), pp. 1423–1429.
- Rouhani, G., Ertekin, Z. C. and Dinc, E. (2017) ‘A new UPLC approach for the quantitation of ephedrine and guaifenesin in a syrup formulation using multivariate optimization strategy’, Journal of Liquid Chromatography & Related Technologies, 40(7), pp. 333–339. doi: 10.1080/10826076.2017.1300171.
- Schwelm, H. M. et al. (2020) ‘Application of a chiral high‐performance liquid chromatography‐tandem mass spectrometry method for the determination of 13 related amphetamine‐type stimulants to forensic samples: Interpretative hypotheses’, Drug Testing and Analysis, 12(9), pp. 1354–1365. doi: 10.1002/dta.2886.
- Sri, R. S., Sri, K. B. and Mounika, C. (2020) ‘A Review on Comparative study of HPLC and UPLC’, Research Journal of Pharmacy and Technology, 13(3), p. 1570. doi: 10.5958/0974-360X.2020.00284.X.
- Yan, T. et al. (2015) ‘UPLC-MS/MS determination of ephedrine, methylephedrine, amygdalin and glycyrrhizic acid in Beagle plasma and its application to a pharmacokinetic study after oral administration of Ma Huang Tang’, Drug Testing and Analysis, 7(2), pp. 158–163. doi: 10.1002/dta.1635.
References
Baharfar, M. et al. (2017) ‘Quantitative analysis of clonidine and ephedrine by a microfluidic system: On-chip electromembrane extraction followed by high performance liquid chromatography’, Journal of Chromatography B, 1068–1069, pp. 313–321. doi: https://doi.org/10.1016/j.jchromb.2017.10.062.
Becerra, A. and Lomas, S. (2016) ‘Separation of MDMA Enantiomers Using a Lux ® 3 µm AMP Chiral Column’. Madrid Ave,Torrance, USA: www.phenomenex.com, pp. 2–3. Available at: www.phenomenex.com.
Castrignanò, E., Lubben, A. and Kasprzyk-Hordern, B. (2016) ‘Enantiomeric profiling of chiral drug biomarkers in wastewater with the usage of chiral liquid chromatography coupled with tandem mass spectrometry’, Journal of Chromatography A, 1438, pp. 84–99. doi: https://doi.org/10.1016/j.chroma.2016.02.015.
Gray, N. et al. (2011) ‘A simple high pH liquid chromatography–tandem mass spectrometry method for basic compounds: Application to ephedrines in doping control analysis’, Journal of Chromatography A, 1218(15), pp. 2098–2105. doi: https://doi.org/10.1016/j.chroma.2010.10.104.
Gray, N. et al. (2013) ‘Comparison of reversed-phase and hydrophilic interaction liquid chromatography for the quantification of ephedrines using medium-resolution accurate mass spectrometry’, Journal of Chromatography A, 1289, pp. 37–46. doi: https://doi.org/10.1016/j.chroma.2013.03.021.
Heaton, J. et al. (2012) ‘Comparison of reversed-phase and hydrophilic interaction liquid chromatography for the separation of ephedrines’, Journal of Chromatography A, 1228, pp. 329–337. doi: https://doi.org/10.1016/j.chroma.2011.09.026.
Ji, B. et al. (2021) ‘Development of a modified quick, easy, cheap, effective, rugged, and safe method based on melamine sponge for multi-residue analysis of veterinary drugs in milks by ultra-performance liquid chromatography tandem mass spectrometry’, Journal of Chromatography A, 1651, p. 462333. doi: https://doi.org/10.1016/j.chroma.2021.462333.
Khan, H. and Ali, J. (2017) ‘UHPLC: Applications in Pharmaceutical Analysis’, Asian Journal of Pharmaceutical Analysis, 7(2), p. 124. doi: 10.5958/2231-5675.2017.00020.5.
Klimczak, I. and Gliszczynska-Swiglo, A. (2015) ‘Comparison of UPLC and HPLC methods for determination of vitamin C’, Food Chemistry, 175, pp. 100–105. doi: 10.1016/j.foodchem.2014.11.104.
Li, X.-L. et al. (2021) ‘Highly sensitive novel fluorescent chiral probe possessing (S)-2-methylproline structures for the determination of chiral amino compounds by ultra-performance liquid chromatography with fluorescence: An application in the saliva of healthy volunteer’, Journal of Chromatography A, p. 462672. doi: https://doi.org/10.1016/j.chroma.2021.462672.
Miranda, L. F. C., Domingues, D. S. and Queiroz, M. E. C. (2016) ‘Selective solid-phase extraction using molecularly imprinted polymers for analysis of venlafaxine, O-desmethylvenlafaxine, and N-desmethylvenlafaxine in plasma samples by liquid chromatography–tandem mass spectrometry’, Journal of Chromatography A, 1458, pp. 46–53. doi: https://doi.org/10.1016/j.chroma.2016.06.024.
Mohamed, D. et al. (2019) ‘UPLC-MS/MS estimation of paracetamol, pseudoephedrine hydrochloride and brompheniramine maleate in plasma: Application to a pharmacokinetic study on healthy Egyptian volunteers based on ethnic difference’, Microchemical Journal, 150, p. 104146. doi: 10.1016/j.microc.2019.104146.
Nahar, L., Onder, A. and Sarker, S. D. (2020) ‘A review on the recent advances in HPLC, UHPLC and UPLC analyses of naturally occurring cannabinoids (2010–2019)’, Phytochemical Analysis, 31(4), pp. 413–457. doi: 10.1002/pca.2906.
Nicolaou, A. G. et al. (2021) ‘Application of an ultra-performance liquid chromatography-tandem mass spectrometric method for the detection and quantification of cannabis in cerumen samples’, Journal of Chromatography A, 1642, p. 462035. doi: https://doi.org/10.1016/j.chroma.2021.462035.
Petrie, B. et al. (2016) ‘Multi-residue analysis of 90 emerging contaminants in liquid and solid environmental matrices by ultra-high-performance liquid chromatography tandem mass spectrometry’, Journal of Chromatography A, 1431, pp. 64–78. doi: https://doi.org/10.1016/j.chroma.2015.12.036.
PPOMN (2010) ‘Identifikasi Efedrin dan Pseudoefedrin dalam Sediaan Padat 07/NA/10’, in Metode Analisis untuk Pengujian Obat dan Makanan di Lingkungan BPOM. Jakarta, pp. 10–15.
Roge, A. B. et al. (2011) ‘Novel achievement of HPLC: UPLC’, International Journal of PharmTech Research, 3(3), pp. 1423–1429.
Rouhani, G., Ertekin, Z. C. and Dinc, E. (2017) ‘A new UPLC approach for the quantitation of ephedrine and guaifenesin in a syrup formulation using multivariate optimization strategy’, Journal of Liquid Chromatography & Related Technologies, 40(7), pp. 333–339. doi: 10.1080/10826076.2017.1300171.
Schwelm, H. M. et al. (2020) ‘Application of a chiral high‐performance liquid chromatography‐tandem mass spectrometry method for the determination of 13 related amphetamine‐type stimulants to forensic samples: Interpretative hypotheses’, Drug Testing and Analysis, 12(9), pp. 1354–1365. doi: 10.1002/dta.2886.
Sri, R. S., Sri, K. B. and Mounika, C. (2020) ‘A Review on Comparative study of HPLC and UPLC’, Research Journal of Pharmacy and Technology, 13(3), p. 1570. doi: 10.5958/0974-360X.2020.00284.X.
Yan, T. et al. (2015) ‘UPLC-MS/MS determination of ephedrine, methylephedrine, amygdalin and glycyrrhizic acid in Beagle plasma and its application to a pharmacokinetic study after oral administration of Ma Huang Tang’, Drug Testing and Analysis, 7(2), pp. 158–163. doi: 10.1002/dta.1635.