İstanbul Journal of Pharmacy

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Research Article


DOI :10.26650/IstanbulJPharm.2024.1223772   IUP :10.26650/IstanbulJPharm.2024.1223772    Full Text (PDF)

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

Manasa Nalla, Sireesha Dodda

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-MS/MS) 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, v/v) at a flow rate of 0.120 mL/min. 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 10–150 ng/mL with r2=0.9980. 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. 

Keywords: Saxagliptin, UPLC-MS/MS, Method development, Validation

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APA

Nalla, M., & Dodda, S. (2024). Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms. İstanbul Journal of Pharmacy, 54(3), 316-321. https://doi.org/10.26650/IstanbulJPharm.2024.1223772


AMA

Nalla M, Dodda S. Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms. İstanbul Journal of Pharmacy. 2024;54(3):316-321. https://doi.org/10.26650/IstanbulJPharm.2024.1223772


ABNT

Nalla, M.; Dodda, S. Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms. İstanbul Journal of Pharmacy, [Publisher Location], v. 54, n. 3, p. 316-321, 2024.


Chicago: Author-Date Style

Nalla, Manasa, and Sireesha Dodda. 2024. “Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms.” İstanbul Journal of Pharmacy 54, no. 3: 316-321. https://doi.org/10.26650/IstanbulJPharm.2024.1223772


Chicago: Humanities Style

Nalla, Manasa, and Sireesha Dodda. “Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms.” İstanbul Journal of Pharmacy 54, no. 3 (Mar. 2025): 316-321. https://doi.org/10.26650/IstanbulJPharm.2024.1223772


Harvard: Australian Style

Nalla, M & Dodda, S 2024, 'Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms', İstanbul Journal of Pharmacy, vol. 54, no. 3, pp. 316-321, viewed 14 Mar. 2025, https://doi.org/10.26650/IstanbulJPharm.2024.1223772


Harvard: Author-Date Style

Nalla, M. and Dodda, S. (2024) ‘Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms’, İstanbul Journal of Pharmacy, 54(3), pp. 316-321. https://doi.org/10.26650/IstanbulJPharm.2024.1223772 (14 Mar. 2025).


MLA

Nalla, Manasa, and Sireesha Dodda. “Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms.” İstanbul Journal of Pharmacy, vol. 54, no. 3, 2024, pp. 316-321. [Database Container], https://doi.org/10.26650/IstanbulJPharm.2024.1223772


Vancouver

Nalla M, Dodda S. Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms. İstanbul Journal of Pharmacy [Internet]. 14 Mar. 2025 [cited 14 Mar. 2025];54(3):316-321. Available from: https://doi.org/10.26650/IstanbulJPharm.2024.1223772 doi: 10.26650/IstanbulJPharm.2024.1223772


ISNAD

Nalla, Manasa - Dodda, Sireesha. “Development and validation of UPLC-MS/MS method for estimation of Saxagliptin in bulk and tablet dosage forms”. İstanbul Journal of Pharmacy 54/3 (Mar. 2025): 316-321. https://doi.org/10.26650/IstanbulJPharm.2024.1223772



TIMELINE


Submitted24.12.2022
Accepted21.07.2024
Published Online30.12.2024

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