Copyright (c) 2023 J. David Blessing Rani, C. Asha Deepti
This work is licensed under a Creative Commons Attribution 4.0 International License.
Liquid Chromatographic-Electron Spray Ionization-Mass Spectroscopy Technique for the Simultaneous Determination of Ethinyl Estradiol & Etonogestrel and Characterization of New Forced Degradation Compounds
Corresponding Author(s) : J. David Blessing Rani
Asian Journal of Chemistry,
Vol. 35 No. 12 (2023): Vol 35 Issue 12, 2023
Abstract
The aim of the current study was to develop, validate a precise, rapid, accurate liquid chromatography-mass spectrometry (LC-MS) method for the simultaneous estimation of ethinyl estradiol and etonogestrel. The retention times of ethinyl estradiol and etonogestrel were found at 3.112 min and 4.399 min, respectively, whereas the linear range were found in the concentration ranges from 0.04-0.23 µg/mL & 3-18 µg/mL with slope coefficient (R2) of 0.9992 and 0.9991 correspondingly. Similarly, the accuracy values for ethinyl estradiol and etonogestrel were found to be 100.5% and 100.1% correspondingly. As per ICH Q2(R1) guidelines, the method was validated with liquid chromatography-mass spectrometry to confirm the newly obtained degradation compounds chemical structures of ethinyl estradiol and etonogestrel.
Keywords
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
- Y.V. Karpievitch, A.D. Polpitiya, G.A. Anderson, R.D. Smith and A.R. Dabney, Ann. Appl. Stat., 4, 1797 (2010); https://doi.org/10.1214/10-AOAS341
- A. Chandewar, Pharm. Anal. Acta, 4, 262 (2013); https://doi.org/10.4172/2153-2435.1000262
- A. Gandhi, S. Guttikar and P. Trivedi, J. Pharm. Anal., 5, 316 (2015); https://doi.org/10.1016/j.jpha.2015.02.002
- R.S. Berkowitz, R.L. Barbieri, A.E. Dunaif, K.J. Ryan and R.L. Barbieri, Kistner’s Gynecology and Women’s Health, St. Louis, Missouri, pp 345-393 (1999).
- K.V. Moray, H. Chaurasia, O. Sachin and B. Joshi, Reprod. Health, 18, 4 (2021); https://doi.org/10.1186/s12978-020-01054-y
- J. Grentzer, C. McNicholas and J.F. Peipert, Expert Rev. Obstetr. Gynecol., 8, 337 (2013); https://doi.org/10.1586/17474108.2013.811941
- G. Petro, T. Spence, M. Patel, A.M. Gertz and C. Morroni, Eur. J. Obstet. Gynecol. Reprod. Biol., 224, 81 (2018); https://doi.org/10.1016/j.contraception.2020.04.013
- L. Thaxton and A. Lavelanet, Int. J. Gynecol. Obstertr., 144, 2 (2019); https://doi.org/10.1002/ijgo.12696
- G.V. Hines, J.N. Quinones, T.N. Walker and A. Waxman, Obstertr. Gynecol., 139, 10S (2022); https://doi.org/10.1097/01.AOG.0000826464.75316.d6
- T.L. Lemke and D.A. Williams, Foye’s Principles of Medicinal Chemistry, Lippincott Williams & Wilkins, p. 1409 (2012).
- H. Hognert, H.K. Kallner, S. Cameron, C. Nyrelli, I. Jawad, R. Heller, A. Aronsson, I. Lindh, L. Benson and K. Gemzell-Danielsson, Human Reprod., 31, 2484 (2016); https://doi.org/10.1093/humrep/dew238
- M.I. Toral, F. Nacaratte and F. Nova, Anal. Lett., 6, 1009 (2014); https://doi.org/10.1080/00032719.2014.968930
- J.J. Berzas, J. Rodríguez and G. Castañeda, Analyst, 122, 41 (1997); https://doi.org/10.1039/a604558h
- S.G. Nair, D.P. Patel, J.G. Frank, B.M. Patel, P. Singhal and D.V. Chaudhary, Biomed. chromatogr., 32, e4165S (2018); https://doi.org/10.1002/bmc.4165
- H. Licea-Perez, S. Wang, C.L. Bowen and E. Yang, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 852, 69 (2007); https://doi.org/10.1016/j.jchromb.2006.12.052
- M.J. López de Alda and D. Barceló, J. Chromatogr. A, 892, 391 (2000); https://doi.org/10.1016/S0021-9673(00)00068-6
- A. Singh, B. Mishra, N. Sharma and K. Mishra, Int. J. Chem. Pharm. Anal., 1, 80 (2014).
- M Sarat, A Rambabu, Int. J. Pharm. Pharm. Sci., 5, 115 (2012).
- K. Shaikh, A. Patil and S. Katare, J. Trace Anal. Food Drugs, 1, 30 (2013); https://doi.org/10.7726/jtafd.2013.1004
References
Y.V. Karpievitch, A.D. Polpitiya, G.A. Anderson, R.D. Smith and A.R. Dabney, Ann. Appl. Stat., 4, 1797 (2010); https://doi.org/10.1214/10-AOAS341
A. Chandewar, Pharm. Anal. Acta, 4, 262 (2013); https://doi.org/10.4172/2153-2435.1000262
A. Gandhi, S. Guttikar and P. Trivedi, J. Pharm. Anal., 5, 316 (2015); https://doi.org/10.1016/j.jpha.2015.02.002
R.S. Berkowitz, R.L. Barbieri, A.E. Dunaif, K.J. Ryan and R.L. Barbieri, Kistner’s Gynecology and Women’s Health, St. Louis, Missouri, pp 345-393 (1999).
K.V. Moray, H. Chaurasia, O. Sachin and B. Joshi, Reprod. Health, 18, 4 (2021); https://doi.org/10.1186/s12978-020-01054-y
J. Grentzer, C. McNicholas and J.F. Peipert, Expert Rev. Obstetr. Gynecol., 8, 337 (2013); https://doi.org/10.1586/17474108.2013.811941
G. Petro, T. Spence, M. Patel, A.M. Gertz and C. Morroni, Eur. J. Obstet. Gynecol. Reprod. Biol., 224, 81 (2018); https://doi.org/10.1016/j.contraception.2020.04.013
L. Thaxton and A. Lavelanet, Int. J. Gynecol. Obstertr., 144, 2 (2019); https://doi.org/10.1002/ijgo.12696
G.V. Hines, J.N. Quinones, T.N. Walker and A. Waxman, Obstertr. Gynecol., 139, 10S (2022); https://doi.org/10.1097/01.AOG.0000826464.75316.d6
T.L. Lemke and D.A. Williams, Foye’s Principles of Medicinal Chemistry, Lippincott Williams & Wilkins, p. 1409 (2012).
H. Hognert, H.K. Kallner, S. Cameron, C. Nyrelli, I. Jawad, R. Heller, A. Aronsson, I. Lindh, L. Benson and K. Gemzell-Danielsson, Human Reprod., 31, 2484 (2016); https://doi.org/10.1093/humrep/dew238
M.I. Toral, F. Nacaratte and F. Nova, Anal. Lett., 6, 1009 (2014); https://doi.org/10.1080/00032719.2014.968930
J.J. Berzas, J. Rodríguez and G. Castañeda, Analyst, 122, 41 (1997); https://doi.org/10.1039/a604558h
S.G. Nair, D.P. Patel, J.G. Frank, B.M. Patel, P. Singhal and D.V. Chaudhary, Biomed. chromatogr., 32, e4165S (2018); https://doi.org/10.1002/bmc.4165
H. Licea-Perez, S. Wang, C.L. Bowen and E. Yang, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 852, 69 (2007); https://doi.org/10.1016/j.jchromb.2006.12.052
M.J. López de Alda and D. Barceló, J. Chromatogr. A, 892, 391 (2000); https://doi.org/10.1016/S0021-9673(00)00068-6
A. Singh, B. Mishra, N. Sharma and K. Mishra, Int. J. Chem. Pharm. Anal., 1, 80 (2014).
M Sarat, A Rambabu, Int. J. Pharm. Pharm. Sci., 5, 115 (2012).
K. Shaikh, A. Patil and S. Katare, J. Trace Anal. Food Drugs, 1, 30 (2013); https://doi.org/10.7726/jtafd.2013.1004