DETERMINATION OF N-NITROSODIMETHYL AMINE (NDMA) AND N-NITROSODIETHYL AMINE (NDEA) IN MEDICINES CONTAINING SARTAN AND ITS DERIVATIVES

Şana Sungur; Muhammed Aljoubasi; Zeki Aydın

Makale detayları

DETERMINATION OF N-NITROSODIMETHYL AMINE (NDMA) AND N-NITROSODIETHYL AMINE (NDEA) IN MEDICINES CONTAINING SARTAN AND ITS DERIVATIVES

Yazarlar:

Şana Sungur | Muhammed Aljoubasi | Zeki Aydın

Yayıncı:

Ankara University

Ana Başlıklar:

Toksikoloji

Dergi:

Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.48 Issue 3, pp.1118-1127

Belge Tipi:

Makale

Yayın Tarihi:

10/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001319062

pISSN:

1015-3918

Anahtar kelimeler:

Özet:

 Objective: In this study, it was aimed to determine the amounts of N-nitrosodimethyl amine NDMA and N-nitrosodiethyl amine NDEA in drugs containing sartan and its derivatives. Material and Method: Medicines containing sartan and its derivatives as active ingredients such as valsartan, losartan, telmisartan, olmesartan, candesartan, irbesartan were purchased from pharmacies. NDMA and NDEA amounts of drugs were determined by headspace GC-MS. Result and Discussion: The highest NDMA concentrations were found in drugs with losartan active ingredient 67.050.15mg kg-1, and the highest NDEA concentrations were found in drugs with candesartan 22.480.06 mg kg-1 and olmesartan 20.13  0.06 mg kg-1 active ingredient. The NDMA contents in each tablet were between 3.6x10-4- 1.7x10-2 mg and the NDEA contents were between 3.3x10-4  8.8x10-3 mg. The acceptable daily intake limits specified by the European Medicines Agency and the Food and Drug Administration are 96 ngday for NDMA and 26.5 ngday for NDEA. It was observed that the values obtained were above the acceptable intake limits even if one tablet was taken per day.

 Objective: In this study, it was aimed to determine the amounts of N-nitrosodimethyl amine NDMA and N-nitrosodiethyl amine NDEA in drugs containing sartan and its derivatives. Material and Method: Medicines containing sartan and its derivatives as active ingredients such as valsartan, losartan, telmisartan, olmesartan, candesartan, irbesartan were purchased from pharmacies. NDMA and NDEA amounts of drugs were determined by headspace GC-MS. Result and Discussion: The highest NDMA concentrations were found in drugs with losartan active ingredient 67.050.15mg kg-1, and the highest NDEA concentrations were found in drugs with candesartan 22.480.06 mg kg-1 and olmesartan 20.13  0.06 mg kg-1 active ingredient. The NDMA contents in each tablet were between 3.6x10-4- 1.7x10-2 mg and the NDEA contents were between 3.3x10-4  8.8x10-3 mg. The acceptable daily intake limits specified by the European Medicines Agency and the Food and Drug Administration are 96 ngday for NDMA and 26.5 ngday for NDEA. It was observed that the values obtained were above the acceptable intake limits even if one tablet was taken per day.

 Objective: In this study, it was aimed to determine the amounts of N-nitrosodimethyl amine NDMA and N-nitrosodiethyl amine NDEA in drugs containing sartan and its derivatives. Material and Method: Medicines containing sartan and its derivatives as active ingredients such as valsartan, losartan, telmisartan, olmesartan, candesartan, irbesartan were purchased from pharmacies. NDMA and NDEA amounts of drugs were determined by headspace GC-MS. Result and Discussion: The highest NDMA concentrations were found in drugs with losartan active ingredient 67.050.15mg kg-1, and the highest NDEA concentrations were found in drugs with candesartan 22.480.06 mg kg-1 and olmesartan 20.13  0.06 mg kg-1 active ingredient. The NDMA contents in each tablet were between 3.6x10-4- 1.7x10-2 mg and the NDEA contents were between 3.3x10-4  8.8x10-3 mg. The acceptable daily intake limits specified by the European Medicines Agency and the Food and Drug Administration are 96 ngday for NDMA and 26.5 ngday for NDEA. It was observed that the values obtained were above the acceptable intake limits even if one tablet was taken per day.

 Amaç: Bu çalışmada, sartan ve türevlerini içeren ilaçların N-nitrosodimetil amin NDMA ve N-nitroso dietil amin NDEA miktarlarının belirlenmesi amaçlanmıştır. Gereç ve Yöntem: Etken madde olarak valsartan, losartan, telmisartan, olmesartan, kandesartan, irbesartan gibi sartan ve türevlerini içeren ilaçlar eczanelerden satın alınmıştır. İlaçların NDMA ve NDEA miktarları headspace GC-MS ile belirlenmiştir. Sonuç ve Tartışma: En yüksek NDMA konsantrasyonu losartan etken maddeli ilaçlarda 67.05  0.15 mg kg-1, en yüksek NDEA konsantrasyonu ise kandesartan 22.480.06 mg kg-1 ve olmesartan 20.13  0.06 mg kg-1 etken maddeli ilaçlarda bulunmuştur. Her tabletteki NDMA içerikleri 3.6x10-4-1.7x10-2 mg arasında, NDEA içerikleri ise 3.3x10-4- 8.8x10-3 mg arasında saptanmıştır. Avrupa İlaç Ajansı ve Gıda ve İlaç İdaresi tarafından belirlenen kabul edilebilir. Günlük alım limitleri NDMA için 96 nggün ve NDEA için 26.5 nggündür. Elde edilen değerlerin günde bir tablet alınsa bile kabul edilebilir alım limitlerinin üzerinde olduğu görülmüştür.

Makale detayları

DETERMINATION OF N-NITROSODIMETHYL AMINE (NDMA) AND N-NITROSODIETHYL AMINE (NDEA) IN MEDICINES CONTAINING SARTAN AND ITS DERIVATIVES

Yazarlar:

Şana Sungur | Muhammed Aljoubasi | Zeki Aydın

Yayıncı:

Ankara University

Ana Başlıklar:

Toksikoloji

Dergi:

Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.48 Issue 3, pp.1118-1127

Belge Tipi:

Makale

Yayın Tarihi:

10/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001319062

pISSN:

1015-3918

Drug

headspace GC-MS

N-nitrosodiethyl amine (NDEA)

N-nitrosodimethyl amine (NDMA)

sartanHeadspace GC-MS

ilaç

N-nitrosodietil amin (NDEA)

N-nitrosodimetil amin (NDMA)

sartan

Sayı

Makale detayları

Yazarlar: Şana Sungur | Muhammed Aljoubasi | Zeki Aydın

Yayıncı: Ankara University

Ana Başlıklar: Toksikoloji

Dergi: Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.48 Issue 3, pp.1118-1127

Belge Tipi: Makale

Yayın Tarihi: 10/2024

Belge Dili: İngilizce

Document ID (Org No.): 2001319062

pISSN: 1015-3918

Sayı

Yazarlar:

Şana Sungur | Muhammed Aljoubasi | Zeki Aydın

Yayıncı:

Ankara University

Ana Başlıklar:

Toksikoloji

Dergi:

Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.48 Issue 3, pp.1118-1127

Belge Tipi:

Makale

Yayın Tarihi:

10/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001319062

pISSN:

1015-3918