Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms

Manasa Nalla; Sireesha Dodda

Makale detayları

Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms

Yazarlar:

Manasa Nalla | Sireesha Dodda

Yayıncı:

Istanbul University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences (Other)

Dergi:

İstanbul Journal of Pharmacy Vol.54 Issue 3, pp.316-321

Belge Tipi:

Makale

Yayın Tarihi:

12/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001340655

pISSN:

2587-2087

Anahtar kelimeler:

Özet:

 Background and Aims: Saxagliptin is an antidiabetic drug used to treat type 2 diabetes mellitus. During the manufacture of bulk and dosage forms, assay of the drugs is important in determining the percentage purity. Hence, this study aimed to develop and validate a simple, rapid, and selective method based on ultra-performance liquid chromatography-Tandem mass spectrometry UPLC-MSMS analysis for the determination of saxagliptin in bulk and tablet dosage forms. Methods: Chromatographic separation was performed using a Waters Acquity UPLC BEH C18 column 2.1 X 50 mm, 1.7 μm with a mobile phase consisting of a mixture of acetonitrile: 0.1 formic acid 60:40, vv at a flow rate of 0.120 mLmin. Separation was performed in 3 min run time. The analyte was ionised and detected by tandem mass spectrometry, which is performed in positive ion and multiple reaction monitoring modes. Results: Linearity was established in the 10150 ngmL with r20.9980. The results were observed to be well within the limits when validation was performed as per the ICH guidelines. Conclusion: The proposed method can be applied successfully for the analysis of saxagliptin in bulk and tablet formulations.

 Background and Aims: Saxagliptin is an antidiabetic drug used to treat type 2 diabetes mellitus. During the manufacture of bulk and dosage forms, assay of the drugs is important in determining the percentage purity. Hence, this study aimed to develop and validate a simple, rapid, and selective method based on ultra-performance liquid chromatography-Tandem mass spectrometry UPLC-MSMS analysis for the determination of saxagliptin in bulk and tablet dosage forms. Methods: Chromatographic separation was performed using a Waters Acquity UPLC BEH C18 column 2.1 X 50 mm, 1.7 μm with a mobile phase consisting of a mixture of acetonitrile: 0.1 formic acid 60:40, vv at a flow rate of 0.120 mLmin. Separation was performed in 3 min run time. The analyte was ionised and detected by tandem mass spectrometry, which is performed in positive ion and multiple reaction monitoring modes. Results: Linearity was established in the 10150 ngmL with r20.9980. The results were observed to be well within the limits when validation was performed as per the ICH guidelines. Conclusion: The proposed method can be applied successfully for the analysis of saxagliptin in bulk and tablet formulations.

 Background and Aims: Saxagliptin is an antidiabetic drug used to treat type 2 diabetes mellitus. During the manufacture of bulk and dosage forms, assay of the drugs is important in determining the percentage purity. Hence, this study aimed to develop and validate a simple, rapid, and selective method based on ultra-performance liquid chromatography-Tandem mass spectrometry UPLC-MSMS analysis for the determination of saxagliptin in bulk and tablet dosage forms. Methods: Chromatographic separation was performed using a Waters Acquity UPLC BEH C18 column 2.1 X 50 mm, 1.7 μm with a mobile phase consisting of a mixture of acetonitrile: 0.1 formic acid 60:40, vv at a flow rate of 0.120 mLmin. Separation was performed in 3 min run time. The analyte was ionised and detected by tandem mass spectrometry, which is performed in positive ion and multiple reaction monitoring modes. Results: Linearity was established in the 10150 ngmL with r20.9980. The results were observed to be well within the limits when validation was performed as per the ICH guidelines. Conclusion: The proposed method can be applied successfully for the analysis of saxagliptin in bulk and tablet formulations.

 Background and Aims: Saxagliptin is an antidiabetic drug used to treat type 2 diabetes mellitus. During the manufacture of bulk and dosage forms, assay of the drugs is important in determining the percentage purity. Hence, this study aimed to develop and validate a simple, rapid, and selective method based on ultra-performance liquid chromatography-Tandem mass spectrometry UPLC-MSMS analysis for the determination of saxagliptin in bulk and tablet dosage forms. Methods: Chromatographic separation was performed using a Waters Acquity UPLC BEH C18 column 2.1 X 50 mm, 1.7 μm with a mobile phase consisting of a mixture of acetonitrile: 0.1 formic acid 60:40, vv at a flow rate of 0.120 mLmin. Separation was performed in 3 min run time. The analyte was ionised and detected by tandem mass spectrometry, which is performed in positive ion and multiple reaction monitoring modes. Results: Linearity was established in the 10150 ngmL with r20.9980. The results were observed to be well within the limits when validation was performed as per the ICH guidelines. Conclusion: The proposed method can be applied successfully for the analysis of saxagliptin in bulk and tablet formulations.

Makale detayları

Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms

Yazarlar:

Manasa Nalla | Sireesha Dodda

Yayıncı:

Istanbul University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences (Other)

Dergi:

İstanbul Journal of Pharmacy Vol.54 Issue 3, pp.316-321

Belge Tipi:

Makale

Yayın Tarihi:

12/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001340655

pISSN:

2587-2087

Saxagliptin

UPLC-MS/MS

Method development

Validation

Sayı

Makale detayları

Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms

Yazarlar: Manasa Nalla | Sireesha Dodda

Yayıncı: Istanbul University

Ana Başlıklar: Pharmacology and Pharmaceutical Sciences (Other)

Dergi: İstanbul Journal of Pharmacy Vol.54 Issue 3, pp.316-321

Belge Tipi: Makale

Yayın Tarihi: 12/2024

Belge Dili: İngilizce

Document ID (Org No.): 2001340655

pISSN: 2587-2087

Saxagliptin

UPLC-MS/MS

Method development

Validation

Sayı

Yazarlar:

Manasa Nalla | Sireesha Dodda

Yayıncı:

Istanbul University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences (Other)

Dergi:

İstanbul Journal of Pharmacy Vol.54 Issue 3, pp.316-321

Belge Tipi:

Makale

Yayın Tarihi:

12/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001340655

pISSN:

2587-2087