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Background <p>Dapagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), and teneligliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), are two important oral anti-diabetic medications that are commonly used to treat type 2 diabetes mellitus. By providing different modes of action, these drugs enhance glucose regulation and reduce the chance of long-term complications associated with diabetes. This research seeks to develop and validate a dependable UV spectrophotometric method for analyzing dapagliflozin and teneligliptin, ensuring it conforms to ICH regulations with high accuracy and precision. The developed UV method was compared with existing UV approaches using a one-way ANOVA test.</p> Results Method <p><b>A</b>: The absorption correction spectrophotometric technique is incorporated into the amplitude of the spectra at 224.60 nm for DAPA and 246.60 nm for TENE. In the process, methanol of HPLC purity was used as solvent. Beer's rule applied to DAPA and TENE at concentrations between 4–12 and 8–24 μg/mL, respectively. <b>Method B</b>: The novel spectrophotometric technique of ratio spectra derivative is used to measure the absorbance for DAPA and TENE at 219.60 nm and 254.20 nm, respectively, using HPLC-grade methanol as the solvent. <b>Method C</b>: The first-order derivative spectrophotometric method was created using distilled water as the solvent. Spectral amplitudes were measured at 266 nm for TENE and 231.60 nm for DAPA. The process demonstrated compliance with Beer's law, with concentration ranges of 4–12 μg/mL for DAPA and 8–24 μg/mL for TENE. The developed method is compared to the previously reported method and the analysis produced a p-value of 1 for the UV technique, which is higher than the significance level of 0.05. The null hypothesis is accepted since there is no statistically significant difference between the approaches. The distinct polarity requirements of DAPA and TENE are reflected in the use of distilled water in Method C and HPLC-grade methanol in Methods A and B. Water slightly shifts λmax and increases baseline noise, which was assessed during robustness studies, while methanol enhances solubility and spectral clarity.</p> Conclusion <p>The UV spectrophotometric approach created for dapagliflozin and teneligliptin has shown itself to be accurate, dependable and cost-effective; it meets all ICH standards for analytical technique validation. This technology provides a dependable approach for routine quality monitoring by making it simpler to quantify these drugs concurrently in pharmaceutical compositions. The one-way ANOVA test conducted demonstrated significant finding.</p>

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Comparative study of UV analytical method and anova application in evaluating Dapagliflozin propanediol monohydrate and teneligliptin hydrobromide hydrate

  • 期刊论文

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  • 发表日期：

    2026年4月3日

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  • Ajumal Hassanar,
  • Sheeja Velayudhan Kutty,
  • Swapna Angadithottunkal Surendran,
  • Yellina Haribabu,
  • Amala Ashokan,
  • Anjali Aravind,
  • Dhithi Vadakkeppat Santhosh,
  • Muhamed Absher

摘要

Background

Dapagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), and teneligliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), are two important oral anti-diabetic medications that are commonly used to treat type 2 diabetes mellitus. By providing different modes of action, these drugs enhance glucose regulation and reduce the chance of long-term complications associated with diabetes. This research seeks to develop and validate a dependable UV spectrophotometric method for analyzing dapagliflozin and teneligliptin, ensuring it conforms to ICH regulations with high accuracy and precision. The developed UV method was compared with existing UV approaches using a one-way ANOVA test.

Results Method

A: The absorption correction spectrophotometric technique is incorporated into the amplitude of the spectra at 224.60 nm for DAPA and 246.60 nm for TENE. In the process, methanol of HPLC purity was used as solvent. Beer's rule applied to DAPA and TENE at concentrations between 4–12 and 8–24 μg/mL, respectively. Method B: The novel spectrophotometric technique of ratio spectra derivative is used to measure the absorbance for DAPA and TENE at 219.60 nm and 254.20 nm, respectively, using HPLC-grade methanol as the solvent. Method C: The first-order derivative spectrophotometric method was created using distilled water as the solvent. Spectral amplitudes were measured at 266 nm for TENE and 231.60 nm for DAPA. The process demonstrated compliance with Beer's law, with concentration ranges of 4–12 μg/mL for DAPA and 8–24 μg/mL for TENE. The developed method is compared to the previously reported method and the analysis produced a p-value of 1 for the UV technique, which is higher than the significance level of 0.05. The null hypothesis is accepted since there is no statistically significant difference between the approaches. The distinct polarity requirements of DAPA and TENE are reflected in the use of distilled water in Method C and HPLC-grade methanol in Methods A and B. Water slightly shifts λmax and increases baseline noise, which was assessed during robustness studies, while methanol enhances solubility and spectral clarity.

Conclusion

The UV spectrophotometric approach created for dapagliflozin and teneligliptin has shown itself to be accurate, dependable and cost-effective; it meets all ICH standards for analytical technique validation. This technology provides a dependable approach for routine quality monitoring by making it simpler to quantify these drugs concurrently in pharmaceutical compositions. The one-way ANOVA test conducted demonstrated significant finding.