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A New Validated Method for Simultaneous Determination of Aerodynamic Particle Size Distribution of Drug Particles of Mometasone Furoate and Formoterol Fumarate Dihydrate in 200 mcg/5 mcg Inhalation Aerosol
Corresponding Author(s) : M. Surya Prakash
Asian Journal of Chemistry,
Vol. 35 No. 8 (2023): Vol 35 Issue 8, 2023
Abstract
Simultaneous determination of aerodynamic particle size distribution (APSD) of drug particles of mometasone furoate and formoterol fumarate dihydrate – 200 mcg/5 mcg inhalation aerosol (MDI) has been developed and reported in this work. The method was developed in consistent with USP <601> inhalation and nasal drug products e.g. aerosols, sprays and powders. The next generation impactor (NGI) was used and operated at 30 ± 5% L/min. The proposed method was demonstrated for sensitivity, minimum number of actuations, diluent volume optimization, mass balance and precision. The proposed method was found to be robust, accurate, linear and precise.
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- O.S. Usmani, Ther. Clin. Risk Manag., 15, 461 (2019); https://doi.org/10.2147/TCRM.S160365
- O.S. Usmani, F. Lavorini, J. Marshall, W.C.N. Dunlop, L. Heron, E. Farrington and R. Dekhuijzen, Respir. Res., 19, 10 (2018); https://doi.org/10.1186/s12931-017-0710-y
- S.W. Stein, AAPS PharmSciTech., 9, 112 (2008); https://doi.org/10.1208/s12249-007-9006-8
- R.I. El-Bagary, M.A. Fouad, M.A. El-Shal and E.H. Tolba, Arabian J. Chem., 9, 493 (2016); https://doi.org/10.1016/j.arabjc.2015.05.005
- H.A. Merey, S.S. El-Mosallamy, N.Y. Hassan, B.A. El-Zeany, Bull. Fac. Pharm., Cairo Univ., 54, 99 (2016); https://doi.org/10.1016/j.bfopcu.2016.02.001
- K.G. Patel, P.M. Shah, P.A. Shah and T.R. Gandhi, J. Food Drug Anal., 24, 610 (2016); https://doi.org/10.1016/j.jfda.2016.02.011
- A.S. Zanwar, D.B. Sen, A.K. Sen and A.K. Seth, Int. J. Pharm. Pharm. Sci., 11, 12 (2016); https://doi.org/10.22159/ijpps.2019v11i2.24799
- Z. Wang, H. Zhang, O. Liu and B. Donovan, J. Chromatogr. A, 1218, 2311 (2011); https://doi.org/10.1016/j.chroma.2011.02.027
- J. Campestrini, J.B. Lecaillon and J. Godbillon, J. Chromatogr B, 704, 221 (1997); https://doi.org/10.1016/s0378-4347(97)00425-8
- N. Pai and S.S. Patil, Der Pharm. Sinica, 4, 15 (2013).
- P.S. Gondhale and B.V. Cheriyan, Turk. J. Pharm. Sci., 19, 35 (2022); https://doi.org/10.4274/tjps.galenos.2021.77177
- A.S. Zanwar, D.B. Sen, D.B. Ruhikar and A.K. Seth, Indo Am. J. Pharm. Res., 4, 5928 (2014).
- P. Sheth, S.W. Stein and P.B. Myrdal, AAPS PharmSciTech., 16, 192 (2015); https://doi.org/10.1208/s12249-014-0210-z
- J. P. Mitchell, M.W. Nagel, V. Avvakoumova, H. MacKay and R. Ali, AAPS PharmSciTech., 10, 243 (2009); https://doi.org/10.1208/s12249-009-9202-9
- W.E. Berger, Expert Rev. Respir Med., 5, 739 (2011); https://doi.org/10.1586/ers.11.71
References
O.S. Usmani, Ther. Clin. Risk Manag., 15, 461 (2019); https://doi.org/10.2147/TCRM.S160365
O.S. Usmani, F. Lavorini, J. Marshall, W.C.N. Dunlop, L. Heron, E. Farrington and R. Dekhuijzen, Respir. Res., 19, 10 (2018); https://doi.org/10.1186/s12931-017-0710-y
S.W. Stein, AAPS PharmSciTech., 9, 112 (2008); https://doi.org/10.1208/s12249-007-9006-8
R.I. El-Bagary, M.A. Fouad, M.A. El-Shal and E.H. Tolba, Arabian J. Chem., 9, 493 (2016); https://doi.org/10.1016/j.arabjc.2015.05.005
H.A. Merey, S.S. El-Mosallamy, N.Y. Hassan, B.A. El-Zeany, Bull. Fac. Pharm., Cairo Univ., 54, 99 (2016); https://doi.org/10.1016/j.bfopcu.2016.02.001
K.G. Patel, P.M. Shah, P.A. Shah and T.R. Gandhi, J. Food Drug Anal., 24, 610 (2016); https://doi.org/10.1016/j.jfda.2016.02.011
A.S. Zanwar, D.B. Sen, A.K. Sen and A.K. Seth, Int. J. Pharm. Pharm. Sci., 11, 12 (2016); https://doi.org/10.22159/ijpps.2019v11i2.24799
Z. Wang, H. Zhang, O. Liu and B. Donovan, J. Chromatogr. A, 1218, 2311 (2011); https://doi.org/10.1016/j.chroma.2011.02.027
J. Campestrini, J.B. Lecaillon and J. Godbillon, J. Chromatogr B, 704, 221 (1997); https://doi.org/10.1016/s0378-4347(97)00425-8
N. Pai and S.S. Patil, Der Pharm. Sinica, 4, 15 (2013).
P.S. Gondhale and B.V. Cheriyan, Turk. J. Pharm. Sci., 19, 35 (2022); https://doi.org/10.4274/tjps.galenos.2021.77177
A.S. Zanwar, D.B. Sen, D.B. Ruhikar and A.K. Seth, Indo Am. J. Pharm. Res., 4, 5928 (2014).
P. Sheth, S.W. Stein and P.B. Myrdal, AAPS PharmSciTech., 16, 192 (2015); https://doi.org/10.1208/s12249-014-0210-z
J. P. Mitchell, M.W. Nagel, V. Avvakoumova, H. MacKay and R. Ali, AAPS PharmSciTech., 10, 243 (2009); https://doi.org/10.1208/s12249-009-9202-9
W.E. Berger, Expert Rev. Respir Med., 5, 739 (2011); https://doi.org/10.1586/ers.11.71