Background: Sensitive determination of molindone and its impurities to be developed for the molindone drug substance/products.
Aim: Effective chromatographic separation was achieved on a
phenyl-hexyl stationary phase for the determination of molindone and its
related impurities.
Methods: The economical and straightforward mobile phase
combination delivered in gradient mode at a flow rate of 0.6 mL/min at 254 nm
using the phenyl-hexyl column with the dimension of (50 × 2.1 mm, 1.9 µ
particles) with the help of an ultra-performance liquid chromatography (UPLC)
system.
Results: 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 square) 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.
Conclusion: 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%. The validated method may be used for
the routine analysis of the determination of related compounds of molindone from
the bulk drug, pharmaceutical preparation, and other quality control samples of
product development.
Author (s) Details
Balaji Nagarajan
Apicore LLC, East Windsor, New Jersey, 08520, United States.
Gunasekar Manoharan
New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New
Jersey, 08902, United States.
Ganapathy Narayanan
Shanmugam
New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New
Jersey, 08902, United States.
Nataraj Palaniyappan
Shri Jagdishprasad Jhabarmal Tibrewala University, Rajasthan, 333001,
India.
Abhinav Yarragunta
Majoring in Computer Engineering, Florida Semiconductor Institute,
University of Florida, United States.
Please see the book here:- https://doi.org/10.9734/bpi/rdcbr/v9/3425
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