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Ultra-performance liquid chromatography determination of related compounds of molindone in drug substances
Balaji Nagarajan (1,*) , Gunasekar Manoharan (2) , Ganapathy Narayanan Shanmugam (3) , Nataraj Palaniyappan (4) , Abhinav Yarragunta (5)
(1) New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, 08902, United States
(2) New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, 08902, United States
(3) New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, 08902, United States
(4) Shri Jagdishprasad Jhabarmal Tibrewala University, Rajasthan, 333001, India
(5) Stanton College Preparatory School is a preparatory high school in Jacksonville, Florida, United States
(*) Corresponding Author
Received: 09 Mar 2022 | Revised: 16 Apr 2022 | Accepted: 20 Apr 2022 | Published: 30 Jun 2022 | Issue Date: June 2022
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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DOI Link: https://doi.org/10.5155/eurjchem.13.2.180-185.2252
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European Journal of Chemistry 2022, 13(2), 180-185 | doi: https://doi.org/10.5155/eurjchem.13.2.180-185.2252 | Get rights and content
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