European Journal of Chemistry

Ultra-performance liquid chromatography determination of related compounds of molindone in drug substances

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Published: Jun 30, 2022
DOI: https://doi.org/10.5155/eurjchem.13.2.180-185.2252
Keywords:
UPLC, Molindone, Separations, Pharmaceuticals, Chromatography, Related compounds
Section
Research Article
Issue
Vol. 13 No. 2 (2022): June 2022
Dates
Received 2022-03-09
Accepted 2022-04-20
Published 2022-06-30
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Balaji Nagarajan
New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, 08902, United States
https://orcid.org/0000-0002-1399-4417
Gunasekar Manoharan
New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, 08902, United States
https://orcid.org/0000-0001-8553-3874
Ganapathy Narayanan Shanmugam
New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, 08902, United States
https://orcid.org/0000-0001-6649-4486
Nataraj Palaniyappan
Shri Jagdishprasad Jhabarmal Tibrewala University, Rajasthan, 333001, India
https://orcid.org/0000-0003-3383-5939
Abhinav Yarragunta
Stanton College Preparatory School is a preparatory high school in Jacksonville, Florida, United States
https://orcid.org/0000-0002-1443-7532

Abstract

Effective chromatographic separation was achieved on a phenyl-hexyl stationary phase (50×2.1 mm, 1.9 micron particles) with the economical and straightforward mobile phase combination delivered in isocratic mode at a flow rate of 0.6 mL/min at 254 nm using a ultra-performance liquid chromatography (UPLC) system. In the developed method, the resolution between molindone and its related compounds was more significant than 2.0. Regression analysis shows an r2 value (correlation coefficient) greater than 0.999 for molindone and its associated compounds. This method could detect related compounds of molindone at a level below 0.009% with respect to a test concentration of 500 µg/mL for a 2.0 µL injection volume. The method has shown good, consistent recoveries for related compounds (90-110%). The test solution was found to be stable in the diluent for 48 hours. The drug was subjected to stress conditions. The mass balance was found to be close to 99.3%.


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How to Cite
(1)
Nagarajan, B.; Manoharan, G.; Shanmugam, G. N.; Palaniyappan, N.; Yarragunta, A. Ultra-Performance Liquid Chromatography Determination of Related Compounds of Molindone in Drug Substances. Eur. J. Chem. 2022, 13, 180-185.

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References

[1]. Junqiu, J.; Meihua, G.; Xiaochang, L.; Jun, C. A kind of synthetic method of improved Molindone. CN:107011237:A, August 4, 2017. https://patents.google.com/patent/CN107011237A/en (accessed April 20, 2022).

[2]. Junqiu, J.; Meihua, G.; Xiaochang, L.; Jun, C. Improved synthesis method of molindone. CN:107011237:B, April 21, 2020. https://patents.google.com/patent/CN107011237B/en (accessed April 20, 2022).

[3]. Hanbauer, M.; Nazir, Z.; Hildebrand, P.; Figini, A.; Liang, L.; Fumagalli, T. Methods of producing molindone and its salts. 9802893, October 31, 2017. https://patents.google.com/patent/US9802893B2/en (accessed April 20, 2022).

[4]. Narasimhachari, N.; Pandurangi, A. K.; Landa, B. A simple HPLC method for the quantitation of molindone in human plasma or serum. J. Liq. Chromatogr. 1988, 11, 983-989.
https://doi.org/10.1080/01483918808068359

[5]. Gawlik, M.; Savic, V.; Jovanovic, M.; Skibiński, R. Mimicking of phase I metabolism reactions of molindone by HLM and photocatalytic methods with the use of UHPLC-MS/MS. Molecules 2020, 25, 1367.
https://doi.org/10.3390/molecules25061367

[6]. Jiang, H.; Li, Y.; Pelzer, M.; Cannon, M. J.; Randlett, C.; Junga, H.; Jiang, X.; Ji, Q. C. Determination of molindone enantiomers in human plasma by high-performance liquid chromatography-tandem mass spectrometry using macrocyclic antibiotic chiral stationary phases. J. Chromatogr. A 2008, 1192, 230-238.
https://doi.org/10.1016/j.chroma.2008.03.048

[7]. Separation of Molindone hydrochloride on Newcrom R1 HPLC column. https://www.sielc.com/separation-of-molindone-hydrochloride-on-newcrom-c18-hplc-column.html (accessed April 20, 2022).

[8]. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ich harmonised tripartite Guideline stability testing: Validation of analytical procedures: text and methodology Q2(R1), https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf (accessed April 20, 2022).

[9]. Chemstation software by Agilent technologies. http://www.chem.agilent.com, https://www.agilent.com/cs/library/usermanuals/Public/G2070-91126_Understanding.pdf (accessed April 20, 2022).

[10]. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ich harmonised tripartite guideline stability testing of new drug substances and products Q1A (R2). https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf (accessed April 20, 2022).

[11]. Minitab Statistical Software, State College, PA: Minitab, Inc. https://www.minitab.com/en-us/products/minitab/ (accessed April 20, 2022).

[12]. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ich harmonised tripartite Guideline stability testing: Photostability testing of new drug substances and products. Q1B https://database.ich.org/sites/default/files/Q1B%20Guideline.pdf (accessed April 20, 2022).

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