Development Of A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Saxagliptine And Dapagliflozin And Its Validation As Per Ich Guidelines

Kommineni, Vinutha; Chowdary, K. P. R.; Prasad, S. V. U. M.

doi:10.5281/zenodo.892231

2017

DOI: 10.5281/zenodo.892231

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Development Of A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Saxagliptine And Dapagliflozin And Its Validation As Per Ich Guidelines

Vinutha Kommineni¹,

K. P. R. Chowdary²,

S. V. U. M. Prasad³

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2020

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Acid Degradation Study of Dapagliflozin: Structural Characterization of Dapagliflozin and its Degradation Products Using Advanced Analytical Techniques and In Silico Toxicity Prediction

Bhuma,

Maddala,

Raghupathi

et al. 2024

Separation Science Plus

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The research investigates the stress degradation behavior of Dapagliflozin (DAP), a type‐2 diabetic treatment, following International Council for Harmonization Guidelines. It found that DAP is stable in thermal, photolytic, neutral, and alkaline hydrolysis conditions, but significant degradation was detected in acid hydrolysis. Two novel degradation products (DPs) were identified and isolated in acid degradation, providing the first documented structural characterization of all two DPs. The identification of DPs was achieved through the use of ultra‐high‐performance liquid chromatography–mass spectrometry, semi‐preparative high‐performance liquid chromatography, and nuclear magnetic resonance spectroscopy for structural characterization. In acid degradation, a total of two primary DPs, degradation products 1 and 2 (DP1 and DP2), were found and separated. It was not previously reported that the two DPs that were generated were all new. This is the first time that these two DPs’ full structural characterizations employing cutting‐edge analytical techniques have been recorded. In the current work, liquid chromatography mass spectroscopy and nuclear magnetic resonance spectroscopy were employed to get a specific confirmation of DP structures. In the further, degrading impurity with lower runtime will also be identified using the current method.

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Acid Degradation Study of Dapagliflozin: Structural Characterization of Dapagliflozin and its Degradation Products Using Advanced Analytical Techniques and In Silico Toxicity Prediction

Bhuma,

Maddala,

Raghupathi

et al. 2024

Separation Science Plus

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show abstract

Degradation Pathway Proposal, Structure Elucidation, and In Silico Toxicity Prediction of Dapagliflozin Propane Diol Hydrolytic Degradation Products

Devrukhakar

Shankar

2020

Chromatographia

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Development Of A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Saxagliptine And Dapagliflozin And Its Validation As Per Ich Guidelines

Cited by 2 publications

References 0 publications

Acid Degradation Study of Dapagliflozin: Structural Characterization of Dapagliflozin and its Degradation Products Using Advanced Analytical Techniques and In Silico Toxicity Prediction

Acid Degradation Study of Dapagliflozin: Structural Characterization of Dapagliflozin and its Degradation Products Using Advanced Analytical Techniques and In Silico Toxicity Prediction

Degradation Pathway Proposal, Structure Elucidation, and In Silico Toxicity Prediction of Dapagliflozin Propane Diol Hydrolytic Degradation Products

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