Synthetic colorants: Analysis in pediatric over the counter  drugs OTCs by HPLC and exposure risk to children

N.A.

Makale detayları

Synthetic colorants: Analysis in pediatric over the counter drugs OTCs by HPLC and exposure risk to children

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmacognosy

Dergi:

Journal of Research in Pharmacy Vol.28 Issue 6, pp.2223-2235

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001334792

pISSN:

2630-6344

Anahtar kelimeler:

Özet:

 Synthetic colorants SCs are a class of pharmaceutical excipients, which could have harmful side effects especially in a vulnerable population like children. This study aimed to develop and validate a simple reverse phase high performance liquid chromatography RP-HPLC to quantitate eight SCs e.g. Tartrazine, Indigo carmine, Sunset yellow, Allura red AC, Carmosine, Ponceu 4R, Fast green FCF, and Brilliant blue FCF in pediatric over the counter medications OTCs and to assess the daily colorants intake through OTCs administration. After a solid phase extraction SPE using ChromabondHR-XAW cartridges, a gradient chromatographic elution was carried out using C18 column, and diode-array detector. Mobile phase composed of 80 mM ammonium acetate pH 7.0 and methanol:acetonitrile 70:30 vv solutions. Validation was performed according to ICH guidelines. The developed method was applied to quantify SCs in pediatric OTCs syrups, suspensions, gummies, and chewable tablets marketed in the Gaza Strip. Separation was completed within 18 minutes. The recovery rates of colorants were in the range of 72.01 - 117.15. The developed method was linear with a correlation coefficient R2  0.9989. Limits of detection LOD and limits of quantitation LOQ ranged between 0.007 - 0.12, and 0.02 - 0.36 μgmL, respectively. The method showed unique selectivity, accuracy, and precision. Application of the developed HPLC method to assay synthetic colorants in different OTCs was successful. Assessment of daily colorant intake showed that the patients were exposed to 45 of the acceptable daily intake ADI of sunset yellow through an OTC. The ratio of SCs should be reduced to a minimum in pediatric formulations.

 Synthetic colorants SCs are a class of pharmaceutical excipients, which could have harmful side effects especially in a vulnerable population like children. This study aimed to develop and validate a simple reverse phase high performance liquid chromatography RP-HPLC to quantitate eight SCs e.g. Tartrazine, Indigo carmine, Sunset yellow, Allura red AC, Carmosine, Ponceu 4R, Fast green FCF, and Brilliant blue FCF in pediatric over the counter medications OTCs and to assess the daily colorants intake through OTCs administration. After a solid phase extraction SPE using ChromabondHR-XAW cartridges, a gradient chromatographic elution was carried out using C18 column, and diode-array detector. Mobile phase composed of 80 mM ammonium acetate pH 7.0 and methanol:acetonitrile 70:30 vv solutions. Validation was performed according to ICH guidelines. The developed method was applied to quantify SCs in pediatric OTCs syrups, suspensions, gummies, and chewable tablets marketed in the Gaza Strip. Separation was completed within 18 minutes. The recovery rates of colorants were in the range of 72.01 - 117.15. The developed method was linear with a correlation coefficient R2  0.9989. Limits of detection LOD and limits of quantitation LOQ ranged between 0.007 - 0.12, and 0.02 - 0.36 μgmL, respectively. The method showed unique selectivity, accuracy, and precision. Application of the developed HPLC method to assay synthetic colorants in different OTCs was successful. Assessment of daily colorant intake showed that the patients were exposed to 45 of the acceptable daily intake ADI of sunset yellow through an OTC. The ratio of SCs should be reduced to a minimum in pediatric formulations.

 Synthetic colorants SCs are a class of pharmaceutical excipients, which could have harmful side effects especially in a vulnerable population like children. This study aimed to develop and validate a simple reverse phase high performance liquid chromatography RP-HPLC to quantitate eight SCs e.g. Tartrazine, Indigo carmine, Sunset yellow, Allura red AC, Carmosine, Ponceu 4R, Fast green FCF, and Brilliant blue FCF in pediatric over the counter medications OTCs and to assess the daily colorants intake through OTCs administration. After a solid phase extraction SPE using ChromabondHR-XAW cartridges, a gradient chromatographic elution was carried out using C18 column, and diode-array detector. Mobile phase composed of 80 mM ammonium acetate pH 7.0 and methanol:acetonitrile 70:30 vv solutions. Validation was performed according to ICH guidelines. The developed method was applied to quantify SCs in pediatric OTCs syrups, suspensions, gummies, and chewable tablets marketed in the Gaza Strip. Separation was completed within 18 minutes. The recovery rates of colorants were in the range of 72.01 - 117.15. The developed method was linear with a correlation coefficient R2  0.9989. Limits of detection LOD and limits of quantitation LOQ ranged between 0.007 - 0.12, and 0.02 - 0.36 μgmL, respectively. The method showed unique selectivity, accuracy, and precision. Application of the developed HPLC method to assay synthetic colorants in different OTCs was successful. Assessment of daily colorant intake showed that the patients were exposed to 45 of the acceptable daily intake ADI of sunset yellow through an OTC. The ratio of SCs should be reduced to a minimum in pediatric formulations.

 Synthetic colorants SCs are a class of pharmaceutical excipients, which could have harmful side effects especially in a vulnerable population like children. This study aimed to develop and validate a simple reverse phase high performance liquid chromatography RP-HPLC to quantitate eight SCs e.g. Tartrazine, Indigo carmine, Sunset yellow, Allura red AC, Carmosine, Ponceu 4R, Fast green FCF, and Brilliant blue FCF in pediatric over the counter medications OTCs and to assess the daily colorants intake through OTCs administration. After a solid phase extraction SPE using ChromabondHR-XAW cartridges, a gradient chromatographic elution was carried out using C18 column, and diode-array detector. Mobile phase composed of 80 mM ammonium acetate pH 7.0 and methanol:acetonitrile 70:30 vv solutions. Validation was performed according to ICH guidelines. The developed method was applied to quantify SCs in pediatric OTCs syrups, suspensions, gummies, and chewable tablets marketed in the Gaza Strip. Separation was completed within 18 minutes. The recovery rates of colorants were in the range of 72.01 - 117.15. The developed method was linear with a correlation coefficient R2  0.9989. Limits of detection LOD and limits of quantitation LOQ ranged between 0.007 - 0.12, and 0.02 - 0.36 μgmL, respectively. The method showed unique selectivity, accuracy, and precision. Application of the developed HPLC method to assay synthetic colorants in different OTCs was successful. Assessment of daily colorant intake showed that the patients were exposed to 45 of the acceptable daily intake ADI of sunset yellow through an OTC. The ratio of SCs should be reduced to a minimum in pediatric formulations.

Makale detayları

Synthetic colorants: Analysis in pediatric over the counter drugs OTCs by HPLC and exposure risk to children

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmacognosy

Dergi:

Journal of Research in Pharmacy Vol.28 Issue 6, pp.2223-2235

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001334792

pISSN:

2630-6344

Synthetic colorants

HPLC-DAD

validation

OTCs

ADI

Sayı

Makale detayları

Synthetic colorants: Analysis in pediatric over the counter drugs OTCs by HPLC and exposure risk to children

Yazarlar: N.A.

Yayıncı: Marmara University

Ana Başlıklar: Pharmacognosy

Dergi: Journal of Research in Pharmacy Vol.28 Issue 6, pp.2223-2235

Belge Tipi: Makale

Yayın Tarihi: 6/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001334792

pISSN: 2630-6344

Synthetic colorants

HPLC-DAD

validation

OTCs

ADI

Sayı

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmacognosy

Dergi:

Journal of Research in Pharmacy Vol.28 Issue 6, pp.2223-2235

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001334792

pISSN:

2630-6344