Skip to content
2000
Volume 20, Issue 9
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

Abstract

Background

Vildagliptin, Dapagliflozin and Metformin Hydrochloride are anti- hyperglycemic agents. Anti-hyperglycemic agents are drugs that stimulate insulin secretion and lower the glucose level in the blood. They were investigated as a medication for Diabetes Mellitus (DM). Various studies have reported the HPLC, HPTLC, LC/MS methods for the estimation of individuals of VILD, DAPA and METF. However, until date stability indicating HPLC analysis method has not been reported for the estimation of VILD, DAPA and METF in combined glucagon secretion in a glucose-dependent manner.

Introduction

The objective of present work was to develop and validate the stability of RP-HPLC method for the estimation of Vildagliptin (VILD), Dapagliflozin (DAPA) and Metformin Hydrochloride (METF) in combined dosage form.

Methods

In this research work, High Performance Liquid Chromatography (HPLC) was used for validation in the chromatography. In the HPLC, Methanol and Potassium Dihydrogen phosphate buffer (85:15 v/v) were used as mobile phases. HPLC analysis was performed at 230 nm. The method was validated with different parameters such as linearity, precision, accuracy, specificity, and robustness, limit of detection (LOD) and limit of quantitation (LOQ). The R values of VILD, DAPA and METF were 6.24 ± 0.05 min, 8.34 ± 0.05 min. and 3.68 ± 0.05 min, respectively. The accuracies of drug recovery were 0.6398%,0.3680%, 0.6398% and over the range of 1–4 µg/ml, 20-80 µg/ml and 15-85 µg/ml of VILD, DAPA and METF, respectively.

Results

Degradation products found in stress conditions did not interfere with the detection of VILD, DAPA and METF; therefore, the proposed technique can be considered stable. Significant degradation products of VILD, DAPA and METF were obtained in an acid at METF at 2.05 ± 0.05 min. (MDP-1) and degradation product for oxidation of METF at 2.11 ± 0.05 min. (MDP-2). When alkaline hydrolysis was conducted, photolytic and thermal conditions were applied alone or in combination with METF, no degradation product of VILD, DAPA and METF was found.

Conclusion

The developed and validation method was satisfactorily applied for the analysis of pharmaceutical preparations and proved specific and accurate for quality control of the cited drugs in their combined dosage form.

© 2024 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cpa/10.2174/0115734129343606241202075124
2024-12-06
2025-09-28

  • From This Site

    /content/journals/cpa/10.2174/0115734129343606241202075124
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. BhavyasriK. SurekhaT. BegumS. SumakanthM. RP-HPLC method for Dapagliflozin and metformin HCl in bulk and combined dosage formulation.Arch. Pharm. Pract.202112410611010.51847/Czxl0wYrYr
     [Google Scholar]
  2. JaniB.R. ShahK.V. KapuparaP.P. Development and validation of uv-spectroscopic first derivative method for simultaneous estimation of dapagliflozin and metformin hydrochloride in synthetic mixture.J. Bioequiry.201511102
     [Google Scholar]
  3. ParmarS.H. Development and validation of UV spectroscopic first derivative and high performance liquid chromatography analytical method for simultaneous estimation of dapagliflozin, propaneodiol in synthetic mixture. Eur. J. Biomed. Pharm. Sci.20185668684
     [Google Scholar]
  4. RP-HPLC method for simultaneous determination of lamivudine, stavudine, and zidovudine in perfusate samples: Application to the estimation of dapagliflozin and metformin in bulk and in synthetic mixture.World J. Pharm. Pharm. Sci.20176721392150
     [Google Scholar]
  5. ChaowuttikulC. PalanuvejC. RuangrungsiN. Quantification of chlorogenic acid, rosmarinic acid, and caffeic acid contents in selected Thai medicinal plants using RP-HPLC-DAD.Braz. J. Pharm. Sci.2020s56e1754710.1590/s2175‑97902019000317547
     [Google Scholar]
  6. LeeM.G. ChoiY.H. LeeI. Effects of diabetes mellitus induced by alloxan on the pharmacokinetics of metformin in rats: restoration of pharmacokinetic parameters to the control state by insulin treatment.J. Pharm. Pharm. Sci.20081118810310.18433/J35P4X18445367
     [Google Scholar]
  7. Martínez-FlórezA. GalizziM. IzquierdoL. BustamanteJ.M. RodriguezA. RodriguezF. Rodríguez-CortésA. AlberolaJ. Repurposing bioenergetic modulators against protozoan parasites responsible for tropical diseases.Int. J. Parasitol. Drugs Drug Resist.202014172710.1016/j.ijpddr.2020.07.00232829099
     [Google Scholar]
  8. BrocksD. GabrR.Q. PadwalR.S. Determination of metformin in human plasma and urine by high-performance liquid chromatography using small sample volume and conventional octadecyl silane column.J. Pharm. Pharm. Sci.201013448649410.18433/J32C7121486526
     [Google Scholar]
  9. SalemH.F. NafadyM.M. AliA.A. KhalilN.M. ElsisiA.A. Evaluation of metformin hydrochloride tailoring bilosomes as an effective transdermal nanocarrier.Int. J. Nanomedicine2022171185120110.2147/IJN.S34550535330695
     [Google Scholar]
  10. UroojA. SundarP.S. VasanthiR. RajaM.A. DuttK.R. RaoK.N. Development And Validation of RP-HPLC method for simultaneous single-pass intestinal perfusion (SPIP) studies.Braz. J. Pharm. Sci.2021571907310.1590/s2175‑97902020000419073
     [Google Scholar]
  11. PatelK.J. ChaudharyA.B. BhadaniS.M. RavalR.J. Stability indicating rp-hplc method development and validation for estimation of dapagliflozin and metformin HCl.World J. Pharm. Pharm. Sci.20176979680910.20959/wjpps20179‑9638
     [Google Scholar]
  12. DeepanT. RaoM.B. DhanarajuM.D. Development of validated stability indicating assay method for simultaneous estimation of metformin and dapagliflozin by RP-HPLC.Eur J Appl Sci.201794189199
     [Google Scholar]
  13. MeetaliM. Development and validation of RP-HPLC Assay method for Vldagliptin using Qbd approach and its application to forced degradation studies.Int. J. Pharm. Sci. Drug Res.201683157165
     [Google Scholar]
  14. SatpathyP.R.V. GoudM. BhagyaB. ShyamalaN. Development and validation of RP-HPLC method for the assay of Vildagliptin.Article. World J. Pharm. Pharmaceut. Sci.20143223032310
     [Google Scholar]
  15. Abu DayyihW. HamadM. MallahE. Abu DayyihA. AwadR. ZakariaZ. ArafatT. Method development and validation of vildagliptin and metformin HCL in pharmaceutical dosage form by reversed phase–high performance liquid chromatography (RP-HPLC).J. Pharmaceut. Sci. Res.20189729652972
     [Google Scholar]
  16. RaosahebJ.R. DabhadeM.P. Rp-hplc method development and validation of vildagliptin in bulk and dosage form.World J. Pharm. Pharm. Sci.20246911611176
     [Google Scholar]
  17. ShrikrishnaB. SugandhaV. NisharaniS. Development and validation of RP-HPLC method for simultaneous estimation of vildagliptin and metformin.Res. J. Pharm. Dosage Form. Tech.2013529598
     [Google Scholar]
  18. GodgeR.K. DhanvateG.S. ShindeG.S. MankarS.D. RP-HPLC method development and validation for determination of metformin and vildagliptin in tablet dosage form.Biol. Forum.2023153471474
     [Google Scholar]
  19. MitaliV. Development and stability indicating HPLC method for Dapagliflozin in API and pharmaceutical dosage form.Int. J. Appl. Pharmaceut.20179533
     [Google Scholar]
  20. JainD. JainS. JainD. AminM. Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride, and glimepiride by RP-HPLC in tablet formulation.J. Chromatogr. Sci.200846650150410.1093/chromsci/46.6.50118647470
     [Google Scholar]
  21. DrashtiA. ShahC. Development and validation of novel RP-HPLC method for the simultaneous determination of remogliflozin and vildagliptin in bulk and in synthetic mixture.J. Pharm. Res. Int.20213340B338349
     [Google Scholar]
  22. UroojA.P. SundarS. VasanthiR. Development and validation of RP-HPLC method for simultaneous estimation of Dapagliflozin and Metformin in bulk and in synthetic mixture.World J. Pharm. Pharm. Sci.20186721392150
     [Google Scholar]
  23. PrasanthiC. ParameswariS. Development and validation of RP-HPLC method for metformin hydrochloride and nateglinide in bulk and combined dosage form.Int. J. Pharm. Pharm. Sci.201684267271
     [Google Scholar]
  24. GedawyA. Al-SalamiH. DassC.R. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide.Yao Wu Shi Pin Fen Xi201927131532230648585
     [Google Scholar]
  25. JayashreeA. A novel RP-HPLC method development and validation for the quantification of a potential anti-diabetic drug metformin hydrochloride in tablet dosage form.Int. J. Curr. Pharm. Res.20221452024
     [Google Scholar]
  26. MishraK. SoniH. NayakG. PatelS.S. SinghaiA.k. Method development and validation of metformin hydrochloride in tablet dosage form.E-J. Chem.20118313091313
     [Google Scholar]
  27. VetapalemR. YejellaR.P. AtmakuriL.R. Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of teneligliptin and metformin.Turkish J. Pharmaceut. Sci.202017214114710.4274/tjps.galenos.2018.1676832454773
     [Google Scholar]
  28. FarooquiM.R. MunjewarS.H.R.R Simultaneous determination of atenolol and metformin hydrochloride by reverse phase high performance liquid chromatography.J. Curr. Pharma Res.201011444810.33786/JCPR.2010.v01i01.011
     [Google Scholar]
  29. SharmaR. ChaturvediS.C. SahooP.K. Simultaneous estimation of metformin hydrochloride and pioglitazone hydrochloride by RPHPLC method from combined tablet dosage form.Indian J. Pharm. Sci.200870338338610.4103/0250‑474X.4301020046754
     [Google Scholar]
  30. DigheN.S. VaradeP.R. ShindeG.S. RaoP.S. Quantitative estimation and validation of dapagliflozin and metformin hydrochloride in pharmaceutical dosage form by RP-HPLC.Asian J. Res. Chem201912313614210.5958/0974‑4150.2019.00028.2
     [Google Scholar]
  31. KarmankarS. TajneM. Development of validated stability indicating HPTLC method for the estimation of Teriflunomide in Bulk and Tablet dosage form.Curr. Pharm. Anal.202016781482210.2174/1573412915666190320151500
     [Google Scholar]
  32. KaleD.L. KakdeR.B. HPTLC estimation of Nateglinide in bulk drug and tablet dosage form.Asian J. Chem.2011231043514354
     [Google Scholar]
  33. BarsagadeA.G. MeshramP. DongareP. Stability indicating RP-HPLC method for the simultaneous estimation of domperidone and lafutidine in bulk and the pharmaceutical dosage form.Int. J. Pharm. Pharmaceut. Sci.202144589594
     [Google Scholar]
  34. KumarR.R. GayatriB. AishwaryaB. ShivasreeC. TriveniD. Analytical method development and validation for simultaneous estimation of Dapagliflozin and Vildagliptin by using RP-HPLC.World J. Pharm. Sci.20241232837
     [Google Scholar]
  35. IngoleL.R. Development of stability indicating RP-HPLC method for estimation of Clemasine fumarate and its pharmaceutical dosage form.Res. J. Pharm. Dosag. Tech.2019128794
     [Google Scholar]
  36. KakdeR.B. SatoneD.D. DongareG. ChilbuleR. MalkhedeY. Method development, validation and impurity profiling of Ticagrelor by acid degradation method.Int. J. Pharm. Tech. Res.201710422523610.20902/IJPTR.2017.10429
     [Google Scholar]
  37. ChardeM. KuraneP. DhabaleP. Development of stability indicating assay method for estimation of Ibuprofen and Fumaditine in combined dosage form in tablet.Int. J. Adv. Pharm. Anal.2015548592
     [Google Scholar]
  38. ChenL. ZhouZ. ShenM. MaA. Simultaneous determination and pharmacokinetic study of metformin and rosiglitazone in human plasma by HPLC-ESI-MS.J. Chromatogr. Sci.20114929410010.1093/chrsci/49.2.9421223632
     [Google Scholar]
  39. PimpaleA. KakdeR. Stability indicating method development and validation for the simultaneous estimation of Rosuvastin Calcium and Clopidogrel Bisulfate in pharmaceutical dosage form by RP-HPLC.Asian J. Pharm. Clin. Res.2020139849010.22159/ajpcr.2020.v13i9.38013
     [Google Scholar]
  40. SusmitaA. RajithaG. RamyaY. Analytical method development and validation of new stability indicating RP-HPLC method for simultaneous estimation of metformin hydrochloride and Empagliflozin in tablet dosage form.Asian J. Pharm. Clin. Res.20192924124410.22159/ajpcr.2019.v12i1.26537
     [Google Scholar]
  41. SakoliM. GulyaI. MollawaM. KuznetsovS. Box-Behnken assisted development and validation of high-performance liquid chromatography method for the simultaneous determination of doxorubicin and vorinostat in polymeric nanoparticles.J. Sep. Sci.2022463e2200731
     [Google Scholar]
  42. KakdeR. BarsagadeA. ChaudharyN. Stability – Indicating HPTLC method for analysis of Ticlopidine in pharmaceutical preparation.JPC201124145149
     [Google Scholar]
  43. AsifE.S. UsmaniS.B. Basics of Pharmaceuticals manufacturing and quality operation –A comprehensive guide.Rautledge202410.1201/9781003366393
     [Google Scholar]
  44. BorisagarS. PatelH. PatelC. A validated stability-indicating HPTLC method for the estimation of gemcitabine HCl in its dosage form.J. Planar Chromatogr. Mod. TLC2012251778010.1556/JPC.25.2012.1.13
     [Google Scholar]
  45. RaoA. RajaT. HarikaB. Development and validation of RP-HPLC method for simultaneous estimation of paracetamol and Lornoxicam in bulk and pharmaceutical dosage form.Mahadev Publication2019
     [Google Scholar]
/content/journals/cpa/10.2174/0115734129343606241202075124
Loading
A Robust RP-HPLC Method for Simultaneous Quantification, Validation and Stability Studies on Vildagliptin (VILD), Dapagliflozin (DAPA) and Metformin Hydrochloride (METF) in its Combined Dosage Formulation
Current Pharmaceutical Analysis 20, 1072 (2024); https://doi.org/10.2174/0115734129343606241202075124
/content/journals/cpa/10.2174/0115734129343606241202075124
/content/journals/cpa/10.2174/0115734129343606241202075124
Loading

Data & Media loading...


  • Article Type:     Research Article
Keyword(s): accuracy; dapagliflozin; linearity; metformin; precision; specificity; validation; Vildagliptin

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test