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Simultaneous Quantification of Olodaterol and Tiotropium Bromide by High Performance Liquid Chromatography
Asian Journal of Chemistry,
Vol. 29 No. 1 (2017): Vol 29 Issue 1
Abstract
The present paper describes a sensitive, precise and accurate RP-HPLC method for the simultaneous quantification of olodaterol and tiotropium bromide. Chromatographic separations were carried out on Thermo Hypersil C8 analytical column (150 mm × 4.6 mm, 5 μ particle size). An isocratic elution system was developed using phosphate buffer:methanol [55:45 v/v]. The pH of the mobile was adjusted to 4.4 with orthophosphoric acid. The elution of the analytes was achieved with a flow rate of 1 mL/min. Detection was made by UV absorbance at a wavelength of 236 nm. The detector response was linear in the concentration range of 12.5-37.5 μg/mL for both the analytes. The limit of detection and limit of quantitation values were found to be 0.037 and 0.124 μg/mL for olodaterol and 0.023 and 0.079 μg/mL for tiotropium bromide, respectively. The method was validated following ICH guidelines. All the parameters of validation were found in the acceptance range.
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- T. Bouyssou, P. Casarosa, E. Naline, S. Pestel, I. Konetzki, P. Devillier and A. Schnapp, J. Pharmacol. Exp. Ther., 334, 53 (2010).
- T. Bouyssou, C. Hoenke, K. Rudolf, P. Lustenberger, S. Pestel, P. Sieger, R. Lotz, C. Heine, F.H. Büttner, A. Schnapp and I. Konetzki, Bioorg. Med. Chem. Lett., 20, 1410 (2010).
- J.A. van Noord, J.J. Smeets, B.M. Drenth, J. Rascher, A. Pivovarova, A.L. Hamilton and P.J.G. Cornelissen, Pulm. Pharmacol. Ther., 24, 666 (2011).
- M. Kato, K. Komamura and M. Kitakaze, Circ. J., 70, 1658 (2006).
- S.J. Keam and G.M. Keating, Treat. Respir. Med., 3, 247 (2004).
- G.M. Keating, Drugs, 72, 273 (2012).
- M. Cazzola, P. Rogliani, J. Ora and M.G. Matera, Expert Rev. Clin. Pharm.,8, 529 (2015).
- G. Milano, V. Zavan, W.M. Natta, A. Martelli and F. Mattioli, Pharm. Therap., 41, 97 (2016).
- Stiolto Respimat (Tiotropium Bromide/Olodaterol Inhalation Spray) Prescribing Information; Ridgefield, Connecticut: Boehringer Ingelheim Pharmaceuticals, Inc.; Jun, 2015; Available at: http://docs.boehringeringelheim.Com/Prescribing%20 Information/PIs/Stiolto%20Respimat/stiolto.pdf. Accessed October 15, 2015.
- ICH Validation of Analytical Procedures; Text and Methodology; Q2(R1), International Conference on Harmonization (2005).
References
T. Bouyssou, P. Casarosa, E. Naline, S. Pestel, I. Konetzki, P. Devillier and A. Schnapp, J. Pharmacol. Exp. Ther., 334, 53 (2010).
T. Bouyssou, C. Hoenke, K. Rudolf, P. Lustenberger, S. Pestel, P. Sieger, R. Lotz, C. Heine, F.H. Büttner, A. Schnapp and I. Konetzki, Bioorg. Med. Chem. Lett., 20, 1410 (2010).
J.A. van Noord, J.J. Smeets, B.M. Drenth, J. Rascher, A. Pivovarova, A.L. Hamilton and P.J.G. Cornelissen, Pulm. Pharmacol. Ther., 24, 666 (2011).
M. Kato, K. Komamura and M. Kitakaze, Circ. J., 70, 1658 (2006).
S.J. Keam and G.M. Keating, Treat. Respir. Med., 3, 247 (2004).
G.M. Keating, Drugs, 72, 273 (2012).
M. Cazzola, P. Rogliani, J. Ora and M.G. Matera, Expert Rev. Clin. Pharm.,8, 529 (2015).
G. Milano, V. Zavan, W.M. Natta, A. Martelli and F. Mattioli, Pharm. Therap., 41, 97 (2016).
Stiolto Respimat (Tiotropium Bromide/Olodaterol Inhalation Spray) Prescribing Information; Ridgefield, Connecticut: Boehringer Ingelheim Pharmaceuticals, Inc.; Jun, 2015; Available at: http://docs.boehringeringelheim.Com/Prescribing%20 Information/PIs/Stiolto%20Respimat/stiolto.pdf. Accessed October 15, 2015.
ICH Validation of Analytical Procedures; Text and Methodology; Q2(R1), International Conference on Harmonization (2005).