The objective concerning this work is to evolve and validate a new gas chromatographic procedure for the simultaneous conclusion of acetone and isopropyl alcohol in Paroxetine. To decide the presence of acetone and isopropyl alcohol in paroxetine, a easy, accurate, and impressionable gas chromatographic method was conceived and validated. Using a flame ionisation indicator (FID) and gradient line, residual solvents were divided on ZB-1, 30 m length 0.53 mm ID, and film diameter 5 m. The injection was completed activity in split mode, with a split percentage of 10:1. Dimethyl acetamide was selected as a diluent to acquire good sensitivity along with the improvement. 1-Propanol was used as an within standard which working for area ratio system.The developed vapor chromatographic method offers symmetrical peak shape, good resolution of 2.3 min and judicious retention opportunity for the solvents acetone 9.21 min and isopropyl intoxicating 9.845 min. The limit of discovery for acetone and isopropyl alcohol was 26.72 µg/ml and 82.96 µg/ml, individually. Limit of quantitation for acetone and isopropyl alcohol was 80.96 µg/ml and 251.39 µg/ml, respectively. Precision was 0.83 and 0.63. Linearity was y = 0.0004x, R2 = 0.9988 for acetone, and y = 0.0001x+0.0021, R2 = 0.9987 for isopropyl intoxicating, and accuracy in addition to robustness is acted and acceptable results were obtained. Hence, The projected, developed procedure was demonstrated as simple, delicate, linearity, correct, and robust, So, this design can be used to determine the leftover organic solvent in Paroxetine drug substance and drug device. The study concluded that it can be secondhand for the determination of leftover solvents in Paroxetine API and also in the done dosage forms place the particular solvent used for the coating purpose in the drug companies and research workshops.
Author(s) Details:
S. K. Abdul Rahaman,
Department of Pharmaceutical Analysis, Nirmala
College of Pharmacy, Atmakur, Mangalagiri, Guntur, Andhra Pradesh, India.
Padmavathi
Sakinala,
Department
of Pharmaceutical Analysis, Nirmala College of Pharmacy, Atmakur, Mangalagiri,
Guntur, Andhra Pradesh, India.
N. Khaleel,
Department of Pharmaceutical Sciences, Acharya Nagarjuna University,
Guntur, Andhra Pradesh, India.
Harekrishna Roy,
Department of Pharmaceutics, Nirmala College of Pharmacy, Atmakur,
Mangalagiri, Guntur, Andhra Pradesh, India.
B.
Pamula Reddy,
Department of Pharmaceutics, Nirmala College of
Pharmacy, Atmakur, Mangalagiri, Guntur, Andhra Pradesh, India.
G.
Sai Sree Lakshmi,
Department
of Pharmaceutical Analysis, Nirmala College of Pharmacy, Atmakur, Mangalagiri,
Guntur, Andhra Pradesh, India.
Please see the link here: https://stm.bookpi.org/NAPR-V1/article/view/10303
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