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Pankaj B. Miniyar
miniyarpankaj@gmail.com
Pankaj B. Miniyar
Sinhgad Technical Education Society's Sinhgad Institute of Pharmacy, Narhe, Pune 411041, India
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Resham D. Kulkarni
Resham D. Kulkarni
Sinhgad Technical Education Society's Sinhgad Institute of Pharmacy, Narhe, Pune 411041, India
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Asha B. Thomas
Asha B. Thomas
Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research Pimpri, Pune 411018, India
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Sohan S. Chitlange
Sohan S. Chitlange
Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research Pimpri, Pune 411018, India
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Summary
Genotoxic impurities can be described as impurities that can induce genetic mutations and chromosomal breaks, or that damage the genetic information within a cell, which may lead to cancer. The European Medical Agency (EMA) and the United States Food and Drug Administration (US FDA) have set a threshold of toxicological concern (TTC) of genotoxic impurities 1.5 µg per day. In a continuous effort to develop an analytical method for the estimation of genotoxic impurities in quetiapine fumarate, a sensitive, simple, and precise high-performance thin-layer chromatography method has been developed and validated for the determination of 2-nitrophenyl (phenyl)sulfane as a genotoxic impurity at trace levels. The limits of detection (LOD) for quetiapine fumarate and 2-nitrophenyl (phenyl)sulfane were found to be 5.11 and 15.5 ng per band, whereas the limits of quantification (LOQ) were observed 0.09 and 0.3 ng per band, respectively. The calibration curve for 2-nitrophenyl (phenyl)sulfane was linear over the concentration range of 10 to 50 ng per band. The method was found to be specific, precise, linear, and accurate for the estimation of 2-nitrophenyl (phenyl)sulfane at trace levels in quetiapine fumarate.
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| Journal of Planar Chromatography - Modern TLC | |
|---|---|
| Language | English |
| Size | A4 |
| Year of Foundation |
1988 |
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1 |
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| Founder | Akadémiai Kiadó |
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| ISSN | 0933-4173 (Print) |
| ISSN | 1789-0993 (Online) |
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