Recent Progress in Analytical Method Development and Validation of Dapagliflozin

Recent advances in analytical methodology for dapagliflozin quantification have highlighted various instrumental approaches crucial for pharmaceutical quality control. Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, requires precise analytical methods for its determination in pharmaceutical formulations. Multiple validated techniques including UV spectrophotometry, reversed-phase high-performance liquid chromatography (RP-HPLC), and high-performance thin-layer chromatography (HPTLC) have emerged for analyzing dapagliflozin alone and in combination with other antidiabetic agents. UV spectrophotometric methods demonstrate simplicity and cost-effectiveness, utilizing various solvents and detecting wavelengths between 210-280 nm. RP-HPLC methods employ C18 columns with diverse mobile phase compositions, achieving efficient separation with retention times typically under 6 minutes. Method validation parameters encompass linearity, precision, accuracy, specificity, and robustness following International Conference on Harmonisation (ICH) guidelines. Reported linear ranges vary from 5-100 μg/mL for UV methods and 10-250 μg/mL for HPLC methods, with correlation coefficients exceeding 0.99. Recovery studies indicate accuracies between 98-102%, while precision studies show relative standard deviations below 2%. Several stability-indicating assays confirm method selectivity and ability to detect degradation products.

• Publication year

  2025

• Venue

  Journal of Pharma Insights and Research

• Publication date

  2025-04-05

• Fields of study

  Not labeled

• Identifiers
  DOI 10.69613/046d6z97
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar

• No claims are published for this paper.

• No concepts are published for this paper.

• Practical Approach to Initiating SGLT2 Inhibitors in Type 2 Diabetes

  2017influential reference
• Estimation of Dapagliflozin from its Tablet Formulation by UV-Spectrophotometry

  2017cited by this paper
• Sodium glucose CoTransporter 2 (SGLT2) inhibitors: Current status and future perspective.

  2016cited by this paper
• Unique UV spectrophotometric method for reckoning of dapagliflozin in bulk and pharmaceutical dosage forms

  2015cited by this paper
• Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture

  2015cited by this paper
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  2015cited by this paper
• DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN SYNTHETIC MIXTURE

  2015cited by this paper
• METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN API BY RP-HPLC AND UV-SPECTROSCOPY

  2014cited by this paper
• Development and Validation of stability-Indicating RP-HPLC method for determination of Dapagliflozin

  2014cited by this paper
• Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial

  2013cited by this paper
• Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control

  2013influential reference
• The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus.

  2013cited by this paper
• Combined antidiabetic benefits of exenatide and dapagliflozin in diabetic mice†

  2013cited by this paper
• Long-Term Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Receiving High Doses of Insulin

  2012influential reference
• Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial

  2012cited by this paper
• Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium–glucose co‐transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus

  2011cited by this paper
• Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study.

  2011cited by this paper
• SIMPLE AND SENSITIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE BY RP-HPLC

  2011cited by this paper
• Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial.

  2010cited by this paper
• Quantitative PCR tissue expression profiling of the human SGLT2 gene and related family members

  2010influential reference
• Dapagliflozin Monotherapy in Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise

  2010cited by this paper
• Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma.

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• In Vitro Characterization and Pharmacokinetics of Dapagliflozin (BMS-512148), a Potent Sodium-Glucose Cotransporter Type II Inhibitor, in Animals and Humans

  2010cited by this paper
• Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

  2008cited by this paper
• [Thin-layer chromatography in drug analysis].

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