Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients

Şana Sungur; Cansel Demetgül

EN

Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients

Öz

Aim: In this study, the determination of N-nitrosodimethyl amine (NDMA) and N-nitrosodiethyl amine (NDEA) contents in medicines containing metformin and sitagliptin as active ingredients was aimed. pharmaceutical Methods: Pharmaceutical products containing metformin and sitagliptin were obtained from local pharmacies. The levels of NDMA and NDEA in these medicines were analyzed using headspace gas chromatography–mass spectrometry (HS-GC-MS). Results: NDMA concentrations were found to range between 0.920 and 1.571 mg.kg-1, while NDEA levels ranged from 1.241 to 2.908 mg.kg-1. On a per-tablet basis, the detected NDMA amounts ranged from 4.59.10-4 to 1.65.10-3 mg, and NDEA amounts ranged from 7.94.10-4 to 3.54.10-3 mg. Conclusion: The values obtained were found to be above the acceptable intake limits (96 ng/day for NDMA and 26.5 ng/day for NDEA).

Anahtar Kelimeler

Drug, headspace GCMS, N-nitrosodiethyl amine (NDEA), N-nitrosodimethyl amine (NDMA)

Kaynakça

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Ayrıntılar

Birincil Dil

İngilizce

Konular

Hasta Güvenliği

Bölüm

Araştırma Makalesi

Yazarlar

Şana Sungur ^*
Türkiye

Cansel Demetgül
Türkiye

Yayımlanma Tarihi

29 Temmuz 2026

Gönderilme Tarihi

25 Nisan 2026

Kabul Tarihi

5 Temmuz 2026

Yayımlandığı Sayı

Yıl 2026 Cilt: 7 Sayı: 3

IZ

https://izlik.org/JA86MW42FF

APA

Sungur, Ş., & Demetgül, C. (2026). Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients. Yeni Yüzyıl Journal of Medical Sciences, 7(3), 119-128. https://izlik.org/JA86MW42FF

AMA

1.Sungur Ş, Demetgül C. Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients. JMS. 2026;7(3):119-128. https://izlik.org/JA86MW42FF

Chicago

Sungur, Şana, ve Cansel Demetgül. 2026. “Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients”. Yeni Yüzyıl Journal of Medical Sciences 7 (3): 119-28. https://izlik.org/JA86MW42FF.

EndNote

Sungur Ş, Demetgül C (01 Temmuz 2026) Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients. Yeni Yüzyıl Journal of Medical Sciences 7 3 119–128.

IEEE

[1]Ş. Sungur ve C. Demetgül, “Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients”, JMS, c. 7, sy 3, ss. 119–128, Tem. 2026, [çevrimiçi]. Erişim adresi: https://izlik.org/JA86MW42FF

ISNAD

Sungur, Şana - Demetgül, Cansel. “Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients”. Yeni Yüzyıl Journal of Medical Sciences 7/3 (01 Temmuz 2026): 119-128. https://izlik.org/JA86MW42FF.

JAMA

1.Sungur Ş, Demetgül C. Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients. JMS. 2026;7:119–128.

MLA

Sungur, Şana, ve Cansel Demetgül. “Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients”. Yeni Yüzyıl Journal of Medical Sciences, c. 7, sy 3, Temmuz 2026, ss. 119-28, https://izlik.org/JA86MW42FF.

Vancouver

1.Şana Sungur, Cansel Demetgül. Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients. JMS [Internet]. 01 Temmuz 2026;7(3):119-28. Erişim adresi: https://izlik.org/JA86MW42FF

Investigation of Nitrosamine Impurities in Pharmaceutical Preparations Containing Metformin and Sitagliptin Active Ingredients

Öz

Anahtar Kelimeler

Öz

Kaynakça

Ayrıntılar

Birincil Dil

Konular

Bölüm

Yazarlar

Yayımlanma Tarihi

Gönderilme Tarihi

Kabul Tarihi

Yayımlandığı Sayı

IZ

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