GC-FID Quantification of N, N-Dimethyl Aminopropyl Chloride, a Genotoxic Impurity, in Imipramine Hydrochloride and Clomipramine Hydrochloride / Panga Chinna, Shet Prakash M., Ramesha Andagar Ramakrishna, Swamy Sreenivasa, Yashbir Singh
Background: Early antidepressant Active Pharmaceutical Ingredients (API), like imipramine hydrochloride and clomipramine hydrochloride, have not been assessed for Genotoxic Impurities (GTI) as per ICHM7. Objective: The main aim of the study was to develop a new simple and sensitive method for the determination of genotoxic impurities in imipramine hydrochloride and clomipramine hydrochloride active pharmaceutical ingredients. Methods: A simple, selective, and sensitive Gas Chromatography (GC) liquid injector method was developed for the quantitative determination of N, N-Dimethyl Aminopropyl Chloride (DAPC) in APIs. This method provided an excellent sensitivity and a typical target analyte level of 4.0 ppm. The DPAC content in the sample was analyzed on ZB-624, 30m x 0.53mm x 3.0μm column interfaced with a Flame Ionization Detector (FID). The developed method was validated as per ICH guidelines. Results: The validated method showed good linearity over the concentration range of LOQ to 120% (1.18 ppm to 4.8 ppm), with a correlation coefficient of 0.9986. Limit Of Detection (LOD) and Limit Of Quantification (LOQ) were found to be 0.36 ppm and 1.18 ppm, respectively. This method showed high sample recovery (>90.0%). Conclusion: The developed method was found to be a simple and sensitive gas chromatography liquid injector method. This method was validated as per ICH guidelines and could be very useful for the determination of a potential genotoxic impurity (DAPC) in imipramine hydrochloride and clomipramine hydrochloride active drug substances, thus ensuring the safety of the patients.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
|---|---|
| Enthalten in: |
Current pharmaceutical analysis - 18(2022), 9, Seite 8 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Chinna, Panga [VerfasserIn] |
|---|
| Links: |
FID Access [lizenzpflichtig] |
|---|
| Umfang: |
1 Online-Ressource (8 p) |
|---|
| Förderinstitution / Projekttitel: |
|
|---|
| PPN (Katalog-ID): |
KFL011170743 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | KFL011170743 | ||
| 003 | DE-627 | ||
| 005 | 20231128145733.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 230613s2022 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)KFL011170743 | ||
| 035 | |a (KFL)prod_DARH_.5932D0F7BF9A99CDA6BEBE8E4F48E4DB4EDC78E2 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 084 | |a PHARM |q DE-84 |2 fid | ||
| 100 | 1 | |a Chinna, Panga |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a GC-FID Quantification of N, N-Dimethyl Aminopropyl Chloride, a Genotoxic Impurity, in Imipramine Hydrochloride and Clomipramine Hydrochloride |c Panga Chinna, Shet Prakash M., Ramesha Andagar Ramakrishna, Swamy Sreenivasa, Yashbir Singh |
| 264 | 1 | |c 2022 | |
| 300 | |a 1 Online-Ressource (8 p) | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a Background: Early antidepressant Active Pharmaceutical Ingredients (API), like imipramine hydrochloride and clomipramine hydrochloride, have not been assessed for Genotoxic Impurities (GTI) as per ICHM7. Objective: The main aim of the study was to develop a new simple and sensitive method for the determination of genotoxic impurities in imipramine hydrochloride and clomipramine hydrochloride active pharmaceutical ingredients. Methods: A simple, selective, and sensitive Gas Chromatography (GC) liquid injector method was developed for the quantitative determination of N, N-Dimethyl Aminopropyl Chloride (DAPC) in APIs. This method provided an excellent sensitivity and a typical target analyte level of 4.0 ppm. The DPAC content in the sample was analyzed on ZB-624, 30m x 0.53mm x 3.0μm column interfaced with a Flame Ionization Detector (FID). The developed method was validated as per ICH guidelines. Results: The validated method showed good linearity over the concentration range of LOQ to 120% (1.18 ppm to 4.8 ppm), with a correlation coefficient of 0.9986. Limit Of Detection (LOD) and Limit Of Quantification (LOQ) were found to be 0.36 ppm and 1.18 ppm, respectively. This method showed high sample recovery (>90.0%). Conclusion: The developed method was found to be a simple and sensitive gas chromatography liquid injector method. This method was validated as per ICH guidelines and could be very useful for the determination of a potential genotoxic impurity (DAPC) in imipramine hydrochloride and clomipramine hydrochloride active drug substances, thus ensuring the safety of the patients | ||
| 700 | 1 | |a Prakash M., Shet |e verfasserin |4 aut | |
| 700 | 1 | |a Ramakrishna, Ramesha Andagar |e verfasserin |4 aut | |
| 700 | 1 | |a Sreenivasa, Swamy |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Yashbir |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Current pharmaceutical analysis |d Sharjah, U.A.E. : Bentham Science Publ., 2005 |g 18(2022), 9, Seite 8 |h Online-Ressource |w (DE-627)KFL000006440 |w (DE-600)2216923-4 |w (DE-576)306832917 |x 1875-676X |7 nnns |
| 773 | 1 | 8 | |g volume:18 |g year:2022 |g number:9 |g pages:8 |
| 856 | 4 | 0 | |u http://pharmazie.proxy.fid-lizenzen.de/fid/bentham-ejournals-pharmazie/www.eurekaselect.com/openurl/content.php?genre=article&issn=1573-4129&volume=18&issue=9&spage=852 |m X:KFL |x Verlag |y FID Access |z lizenzpflichtig |
| 912 | |a ZDB-1-BEJ | ||
| 912 | |a GBV_KFL | ||
| 912 | |a FID-PHARM | ||
| 935 | |i IMPORT_0628_prod_DARH_03 | ||
| 951 | |a AR | ||
| 952 | |d 18 |j 2022 |e 9 |h 8 | ||