Analysis of Residual Solvents-Impurities by HS-GC-FID: Case of Seven Samples of Ciprofloxacin API

Derouicha Matmour

Makale detayları

Analysis of Residual Solvents-Impurities by HS-GC-FID: Case of Seven Samples of Ciprofloxacin API

Yazarlar:

Derouicha Matmour

Yayıncı:

Hacettepe University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.32-42

Belge Tipi:

Makale

Yayın Tarihi:

1/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001284500

pISSN:

2458-8806

Anahtar kelimeler:

Özet:

 Organic volatile impurities known as residual solvents might appear during the production of active pharmaceutical ingredients APIs. Analysis of residual solvents in pharmaceutical products is necessary due to the potential risk they provide to human health due to their toxicity and unfavorable side effects, as well as the possibility that they may change the physicochemical properties of the pharmaceutical product. The goal of this study was to analysis 29 residual solvents-impurities using Head Space Gas Chromatography with Flame Ionization Detector HS-GC-FID in seven Ciprofloxacin Hydrochloride API samples that were gathered from seven pharmaceutical companies located in Algeria. A flame-ionization detector and a silica column covered with a 1.8 m layer of phase G43 were both installed in the GC. Helium served as the carrier gas, having a split ratio of 1:5 and a linear velocity of 35 cms. The temperature of the column began at 40 C and increased to 240 C. The temperature of the injection was 140 C, while the detector temperature was 250 C. Twenty-nine organic solvents belong to classes 1 and 2 were analyzed in seven samples of Ciprofloxacin Hydrochloride API whose control is mandatory because of their carcinogenic and intrinsic toxicity. Only five solvents were identified wich are Hexane, Toluene, Acetonitrile, Methanol and Dichloromethane in the different samples. All samples collected satisfied the test of identification, so, the confirmation and the quantification procedures werent realized. The HS-GC-FID technique used showed that the identified solvents differ from one sample to another of the same molecule. This showed that manufacturers didnt often use the same solvents to produce the same API, which justifies that residual organic solvent tests werent usually mentioned in the specific monographs.

 Organic volatile impurities known as residual solvents might appear during the production of active pharmaceutical ingredients APIs. Analysis of residual solvents in pharmaceutical products is necessary due to the potential risk they provide to human health due to their toxicity and unfavorable side effects, as well as the possibility that they may change the physicochemical properties of the pharmaceutical product. The goal of this study was to analysis 29 residual solvents-impurities using Head Space Gas Chromatography with Flame Ionization Detector HS-GC-FID in seven Ciprofloxacin Hydrochloride API samples that were gathered from seven pharmaceutical companies located in Algeria. A flame-ionization detector and a silica column covered with a 1.8 m layer of phase G43 were both installed in the GC. Helium served as the carrier gas, having a split ratio of 1:5 and a linear velocity of 35 cms. The temperature of the column began at 40 C and increased to 240 C. The temperature of the injection was 140 C, while the detector temperature was 250 C. Twenty-nine organic solvents belong to classes 1 and 2 were analyzed in seven samples of Ciprofloxacin Hydrochloride API whose control is mandatory because of their carcinogenic and intrinsic toxicity. Only five solvents were identified wich are Hexane, Toluene, Acetonitrile, Methanol and Dichloromethane in the different samples. All samples collected satisfied the test of identification, so, the confirmation and the quantification procedures werent realized. The HS-GC-FID technique used showed that the identified solvents differ from one sample to another of the same molecule. This showed that manufacturers didnt often use the same solvents to produce the same API, which justifies that residual organic solvent tests werent usually mentioned in the specific monographs.

 Organic volatile impurities known as residual solvents might appear during the production of active pharmaceutical ingredients APIs. Analysis of residual solvents in pharmaceutical products is necessary due to the potential risk they provide to human health due to their toxicity and unfavorable side effects, as well as the possibility that they may change the physicochemical properties of the pharmaceutical product. The goal of this study was to analysis 29 residual solvents-impurities using Head Space Gas Chromatography with Flame Ionization Detector HS-GC-FID in seven Ciprofloxacin Hydrochloride API samples that were gathered from seven pharmaceutical companies located in Algeria. A flame-ionization detector and a silica column covered with a 1.8 m layer of phase G43 were both installed in the GC. Helium served as the carrier gas, having a split ratio of 1:5 and a linear velocity of 35 cms. The temperature of the column began at 40 C and increased to 240 C. The temperature of the injection was 140 C, while the detector temperature was 250 C. Twenty-nine organic solvents belong to classes 1 and 2 were analyzed in seven samples of Ciprofloxacin Hydrochloride API whose control is mandatory because of their carcinogenic and intrinsic toxicity. Only five solvents were identified wich are Hexane, Toluene, Acetonitrile, Methanol and Dichloromethane in the different samples. All samples collected satisfied the test of identification, so, the confirmation and the quantification procedures werent realized. The HS-GC-FID technique used showed that the identified solvents differ from one sample to another of the same molecule. This showed that manufacturers didnt often use the same solvents to produce the same API, which justifies that residual organic solvent tests werent usually mentioned in the specific monographs.

 Organic volatile impurities known as residual solvents might appear during the production of active pharmaceutical ingredients APIs. Analysis of residual solvents in pharmaceutical products is necessary due to the potential risk they provide to human health due to their toxicity and unfavorable side effects, as well as the possibility that they may change the physicochemical properties of the pharmaceutical product. The goal of this study was to analysis 29 residual solvents-impurities using Head Space Gas Chromatography with Flame Ionization Detector HS-GC-FID in seven Ciprofloxacin Hydrochloride API samples that were gathered from seven pharmaceutical companies located in Algeria. A flame-ionization detector and a silica column covered with a 1.8 m layer of phase G43 were both installed in the GC. Helium served as the carrier gas, having a split ratio of 1:5 and a linear velocity of 35 cms. The temperature of the column began at 40 C and increased to 240 C. The temperature of the injection was 140 C, while the detector temperature was 250 C. Twenty-nine organic solvents belong to classes 1 and 2 were analyzed in seven samples of Ciprofloxacin Hydrochloride API whose control is mandatory because of their carcinogenic and intrinsic toxicity. Only five solvents were identified wich are Hexane, Toluene, Acetonitrile, Methanol and Dichloromethane in the different samples. All samples collected satisfied the test of identification, so, the confirmation and the quantification procedures werent realized. The HS-GC-FID technique used showed that the identified solvents differ from one sample to another of the same molecule. This showed that manufacturers didnt often use the same solvents to produce the same API, which justifies that residual organic solvent tests werent usually mentioned in the specific monographs.

Makale detayları

Analysis of Residual Solvents-Impurities by HS-GC-FID: Case of Seven Samples of Ciprofloxacin API

Yazarlar:

Derouicha Matmour

Yayıncı:

Hacettepe University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.32-42

Belge Tipi:

Makale

Yayın Tarihi:

1/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001284500

pISSN:

2458-8806

Residual solvents

Solvents-impurties

Ciprofloxacin Hydrochloride

Fluoroquinolone

Antibiotic

HS-GC-FID

HS-GC-FID

Residual solvents

Solvents-impurities

Ciprofloxacin Hydrochloride

Fluoroquinolone

Antibiotic

Sayı

Makale detayları

Yazarlar: Derouicha Matmour

Yayıncı: Hacettepe University

Ana Başlıklar: Pharmacology and Pharmaceutical Sciences

Dergi: Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.32-42

Belge Tipi: Makale

Yayın Tarihi: 1/2023

Belge Dili: İngilizce

Document ID (Org No.): 2001284500

pISSN: 2458-8806

Sayı

Yazarlar:

Derouicha Matmour

Yayıncı:

Hacettepe University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.32-42

Belge Tipi:

Makale

Yayın Tarihi:

1/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001284500

pISSN:

2458-8806