Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety
In the current study, a simple, rapid, and sensitive analytical method was developed and validated for the determination and quantification of four nitrosamine drug substance-related impurities (NDSRIs) in Risperidone drug substance. Chromatographic separation was achieved on an ACE-5 PFP C18 column...
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| Language: | English |
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Elsevier
2025-08-01
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| Series: | Talanta Open |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666831925000190 |
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| author | Hitesh Thumbar Pankajkumar Nariya Bhavin Dhaduk |
| author_facet | Hitesh Thumbar Pankajkumar Nariya Bhavin Dhaduk |
| author_sort | Hitesh Thumbar |
| collection | DOAJ |
| description | In the current study, a simple, rapid, and sensitive analytical method was developed and validated for the determination and quantification of four nitrosamine drug substance-related impurities (NDSRIs) in Risperidone drug substance. Chromatographic separation was achieved on an ACE-5 PFP C18 column (150 mm × 4.6 mm × 3 µm) using gradient elution with 0.2 % formic acid and methanol. The method utilized a flow rate of 0.8 mL/min, an injection volume of 5 µL, and a column temperature of 40 °C. Positive electrospray ionization (ESI) in multiple reaction monitoring (MRM) mode was used for quantification. The limit of detection (LOD) and limit of quantification (LOQ) ranged from 0.12 to 0.46 and 0.23–0.93 µg/mL, respectively. The calibration curves for NDIRs impurities (0.23–185.72 µg/mL) exhibited R² values between 0.998 and 0.999. Recoveries ranged varied from 94.9 to 124.4 %, with % RSD < 15.0 %. The results indicated that the method is reliable for monitoring all NINA, NBOP, NBP, and NB impurities in Risperidone. |
| format | Article |
| id | doaj-art-6d9944d193de4b6b82a831e0a04f9b9e |
| institution | Kabale University |
| issn | 2666-8319 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
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| series | Talanta Open |
| spelling | doaj-art-6d9944d193de4b6b82a831e0a04f9b9e2025-02-08T05:01:27ZengElsevierTalanta Open2666-83192025-08-0111100416Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safetyHitesh Thumbar0Pankajkumar Nariya1Bhavin Dhaduk2Department of Chemistry, School of Science, RK University, Rajkot, IndiaDepartment of Chemistry, Faculty of Science, Atmiya University, Rajkot, IndiaDepartment of Chemistry, School of Science, RK University, Rajkot, India; Department of Chemistry, Faculty of Science, Atmiya University, Rajkot, India; Corresponding author.In the current study, a simple, rapid, and sensitive analytical method was developed and validated for the determination and quantification of four nitrosamine drug substance-related impurities (NDSRIs) in Risperidone drug substance. Chromatographic separation was achieved on an ACE-5 PFP C18 column (150 mm × 4.6 mm × 3 µm) using gradient elution with 0.2 % formic acid and methanol. The method utilized a flow rate of 0.8 mL/min, an injection volume of 5 µL, and a column temperature of 40 °C. Positive electrospray ionization (ESI) in multiple reaction monitoring (MRM) mode was used for quantification. The limit of detection (LOD) and limit of quantification (LOQ) ranged from 0.12 to 0.46 and 0.23–0.93 µg/mL, respectively. The calibration curves for NDIRs impurities (0.23–185.72 µg/mL) exhibited R² values between 0.998 and 0.999. Recoveries ranged varied from 94.9 to 124.4 %, with % RSD < 15.0 %. The results indicated that the method is reliable for monitoring all NINA, NBOP, NBP, and NB impurities in Risperidone.http://www.sciencedirect.com/science/article/pii/S2666831925000190RisperidoneMass spectrometryNDIRsQuantification |
| spellingShingle | Hitesh Thumbar Pankajkumar Nariya Bhavin Dhaduk Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety Talanta Open Risperidone Mass spectrometry NDIRs Quantification |
| title | Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety |
| title_full | Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety |
| title_fullStr | Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety |
| title_full_unstemmed | Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety |
| title_short | Advanced LC-MS/MS method for selective quantification of nitrosamine impurities in Risperidone: Enhancing drug safety |
| title_sort | advanced lc ms ms method for selective quantification of nitrosamine impurities in risperidone enhancing drug safety |
| topic | Risperidone Mass spectrometry NDIRs Quantification |
| url | http://www.sciencedirect.com/science/article/pii/S2666831925000190 |
| work_keys_str_mv | AT hiteshthumbar advancedlcmsmsmethodforselectivequantificationofnitrosamineimpuritiesinrisperidoneenhancingdrugsafety AT pankajkumarnariya advancedlcmsmsmethodforselectivequantificationofnitrosamineimpuritiesinrisperidoneenhancingdrugsafety AT bhavindhaduk advancedlcmsmsmethodforselectivequantificationofnitrosamineimpuritiesinrisperidoneenhancingdrugsafety |