Author(s):
Prushti P. Bhakhar, Hiral S. Popaniya, Khushi V. Rathod, Payal N. Vaja
Email(s):
hpopaniya@gmail.com
DOI:
10.52711/2231-5675.2026.00021
Address:
Prushti P. Bhakhar1, Hiral S. Popaniya2*, Khushi V. Rathod3, Payal N. Vaja4
1,3Research Scholar, School of Pharmacy, Dr. Subhash University, Junagadh (362001), Gujarat, India.
2,4Assistant Professor, School of Pharmacy, Dr. Subhash University, Junagadh (362001), Gujarat, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 2,
Year - 2026
ABSTRACT:
This review gives an overall overview of the different analytical methods available to determine dapagliflozin and pioglitazone, which are used to treat people suffering from type 2 Diabetes Mellitus. Accurate measurement of these two drugs is essential for testing their effect on humans in many ways; they can there for help researchers understand their safety profiles and help ensure that all drugs sold as medicine meet certain criteria (Quality Control). There are many different analytical chemistries available to measure dapagliflozin and pioglitazone in bulk and pharmaceutical preparations, as well as in human biological materials. Evaluating the various analytical methods available, we are specifically referring to methods of validation: For example, when evaluating an absolute measure of dapagliflozin and pioglitazone, we would evaluate the validity of the method by determining its precision, and Accuracy; therefore, this method would also be called Relative Precision and Relative Accuracy, using the validated dose concentration. Analytical methods are generally considered to be highly specific, therefore creating strong, reliable and reproducible analytical method should be selected based on the needs regarding accuracy, reliability, and cost. Some examples of analytical methods that could be used would include RP-HPLC, HPTLC, UV Spectroscopy, and Stability Testing, along with the new developments being made in analytical chemistry techniques.
Cite this article:
Prushti P. Bhakhar, Hiral S. Popaniya, Khushi V. Rathod, Payal N. Vaja. Contemporary Trends in Analytical Method Development for Dapagliflozin and Pioglitazone: A Critical Review of Spectroscopic and Chromatographic Approaches. Asian Journal of Pharmaceutical Analysis. 2026; 16(2):137-4. doi: 10.52711/2231-5675.2026.00021
Cite(Electronic):
Prushti P. Bhakhar, Hiral S. Popaniya, Khushi V. Rathod, Payal N. Vaja. Contemporary Trends in Analytical Method Development for Dapagliflozin and Pioglitazone: A Critical Review of Spectroscopic and Chromatographic Approaches. Asian Journal of Pharmaceutical Analysis. 2026; 16(2):137-4. doi: 10.52711/2231-5675.2026.00021 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-2-11
REFERENCE:
1. Dhillon S, Dapagliflozin: A Review in Type 2 Diabetes. Drugs. 2019; 79(10): 1135-1146. DOI: 10.1007/s40265-019-01148-3
2. Jabbour S, Durability of response to dapagliflozin: a review oflong-term efficacy and safety. Current Medical Research and Opinion. 2017; 33(9): 1685-1696. DOI:10.1080/03007995.2017.1354822
3. ode BW, Garg SK. The emerging role of adjunctive noninsulin antihyperglycemic therapy in the management of type 1 diabetes. Endocr Pract. 2016; 22(2): 220–30.
4. Ahmed-Sarwar N, Nagel AK, Leistman S, et al. SGLT-2 inhibitors: is there a role in type 1 diabetes mellitus management? Ann Pharmacother. 2017; 51(9): 791–6.
5. Chen J, Fan F, Wang JY, et al. The efficacy and safety of SGLT2 inhibitors for adjunctive treatment of type 1 diabetes: a systematic review and meta-analysis. Sci Rep. 2017; 7: 44128.
6. European Medicines Agency. Actos: summary of product characteristics [online].
7. Takeda Pharmaceuticals America Inc. Actos (pioglitazone hy-drochloride) tablets prescribing information [online].
8. Nationallibraryofmedicine.Dapagliflozin[Imageoninternet]Availablefrom:https://pubchem.ncbi.nlm.nih.gov/compound/Dapagliflozin
9. Tushar Raut, Dr. Deokar G.S, Rupali Kadam* and Pranali Patil - Scientific Figure on ResearchGate. Available from: https:// www.researchgate.net/figure/Chemical-structure-of-Pioglitazone-hydrochloride.
10. TABLE 1 Obermeier M, Yao M, Khanna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug metabolism and disposition. 2010; 38(3): 405-14.
11. Al-Majed A, Bakheit AH, Abdel Aziz HA, Alharbi H, Al-Jenoobi FI: Pioglitazone. Profiles Drug Subst Excip Relat Methodol. 2016; 41: 379-438. doi: 10.1016/bs.podrm.2015.11.002. Epub 2016 Feb 2.
12. Yue Sun, Dong Yan, ZiruiHao, Lijuan Cui, GuipingLiMedical Science Monitor: International Medical Journal of Experimental and Clinical Research 26, e921891-1, 2020
13. Smith U. Pioglitazone: mechanism of action. International journal of clinical practice. Supplement. 2001 Sep 1(121): 13-8
14. Mante GV, Gupta KR, Hemke AT. Estimation of dapagliflozinfrom its tablet formulation by UV-spectrophotometry. Pharm Methods. 2017; 8(2): 102-7.
15. Karuna PC, China E, Rao MB. Unique UV spectrophotometric method for reckoning of Dapagliflozin in bulk and pharmaceutical dosage forms. Journal of Chemical and Pharmaceutical Research.2015; 7(9): 45-9.
16. Debata J, Kumar S, Jha SK, Khan A. A New RP-HPLC method development and validation of dapagliflozin in bulk and tablet dosage form International Journal of Drug Development and Research. 2017; 9(2): 48-51.
17. Mante G, Hemke A, Umekar M .RP-HPLC Method for Estimation of Dapagliflozin from its Tablet. International Journal of Chemtech Research. 2018; 11(1): 242-248.
18. Sanagapati M, Dhanalakshmi K, Reddy NG, Sreenivasa S. Development and Validation of stability- Indicating RP-HPLC method for determination of Dapagliflozin. Journal of Advance d Pharmacy Education & Research. 2014; 4(3): 350-353.
19. Basha S, Sravanthi P. Development and validation of dapagliflozin by reversed-phase high-performance liquid chromatography method and it’s forced degradation studies. Asian Journal of Pharmaceutical and Clinical Research. 2017; 10(11):101-5.
20. Sanagapati M, Dhanalakshmi K, Reddy NG, Sreenivasa S. Method development and validation of dapagliflozin in API by RP-HPLC and UV-spectroscopy. International Journal of Pharmaceutical Sciences and Drug Research. 2014; 6(3): 250-252
21. Sarkar S, Patel V. Method development and validation of dapagliflozine drug in bulk and tablet dosage form by RP-HPLC International Journal of Pharma Research and Health Sciences. 2017; 5(4):1755-9.
22. Verma MV, Patel CJ, Patel MM. Development and stability indicating HPLC method for dapagliflozin in API and pharmaceutical dosage form. International Journal of Applied Pharmaceutics. 2017; 9(5): 33-41.
23. Suma BV, Deveswaran R, Premnath SH. Anewhigh-performancethin layer chromatographic method development and validation ofdapagliflozin in bulk and tablet dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2019; 11: 58-63.
24. Khagga B, Thaneeru S, Samreen B, Mogili S. RP-HPLC Methodfor Dapagliflozin and Metformin HCL in Bulk and Combined Formulation. Archives of Pharmacy Practice. 2022; 12(4): 106-10.
25. Bhavyasri K, Surekha T, Sumakanth M. A Novel MethodDevelopment and Validation of Dapagliflozin and Metormin Hydrochloride using Simultaneous Equation Method by UV–Visible Spectroscopy in Bulk and Combined PharmaceuticalFormulation including Forced Degradation Studies. International Journal of Pharmaceutical Sciences and Research. Sci Res. 2020; 12(8): 1100-5.
26. Jani S, Shukla R, Patel P, Mehta B, Detholia K. Quantitative estimation of sitagliptin and dapagliflozin propanediol monohydrate in synthetic mixture using 1st order derivative spectroscopy simultaneous spectrophotometric analysis. International Journal of Pharmaceutical Chemistry and Analysis. 2022; 9(1): 28-34.
27. Manasa M, Aanandhi VM. Stability indicating simultaneous method development and validation of dapagliflozin and saxagliptin by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(2): 1045-9.
28. Patel YD, Patel PR, Bhatt J, Mehta B, Detholia K. Quantitative computation and stability evaluation of phase III composition
29. Patel YD, Patel PR, Bhatt J, Mehta B, Detholia K. Quantitative computation and stability evaluation of phase III composition. By RP-HPLC. Journal of Applied Pharmaceutical Science. 2022; 12(06): 148–155.
30. Boggula N, Pandiyan PS. Development and validation of RP HPLC method for the simultaneous estimation of dapagliflozin and saxagliptin in bulk and pharmaceutical dosage forms. International Journal of Pharmaceutical Sciences and Research. 2021; 12(1): 314-320.
31. Kommineni V, Chowdary KP, Prasad SV. Development and validation of a new HPLC method for the simultaneous estimation of saxagliptine and dapagliflozin and its application in pharmacokinetic studies. International Research Journal of Pharmacy and Medical Sciences. 2018; 1(6).
32. Gundala A, Prasad KV, Koganti B. Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form. Brazilian Journal of Pharmaceutical Sciences. 2019.
33. Vankalapati KR, Alegete P, and Boodida S. Stability-indicating HPLC method development and validation for simultaneous estimation of metformin, dapagliflozin, and saxagliptin in bulk drug and pharmaceutical dosage form biomedical Chromatography. 2022; 36(7): 5384
34. Vinu thakom mineni, K.P.R. Chowdary, S.V.U.M. Prasad. Formulation of Dapagliflozin and Saxagliptin Tablets and In vitro Evaluation by RP-HPLC Method. Asian Journal of Pharmaceutical Analysis. 2019; 9(2): 93-98. Doi: 10.5958/22315675.2019.00018.8
35. Sayali S. More, Sandeep S. Sonawane, Santosh S. Chhajed, Sanjay J. Kshirsagar. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Tablets. Asian Journal of Pharmacy and Technology. 2018; 8(3): 145-148. Doi: 10.5958/2231-5713.2018.00023.5
36. Hiral S. Popaniya, Dinesh K. Dangar Eco-Friendly LC-MS/MS Method for quantification of dapagliflozin and pioglitazonevin combined dosage form: Development, validation and agree assessment. Indian Journal of National Science. 2025.
37. Pavan K. Regeti, B. Sunitha, C. Parthiban, M. Sudhakar. Method Development and Validation for Simultaneous Estimation of Dapagliflozin and Vildagliptin in Pharmaceutical Dosage Form by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2024; 14(4): 229-3.
38. Disha H. Joshi, Jimish R. Patel. Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate in Synthetic Mixture. Asian Journal of Pharmaceutical Research.2025; 15(4): 355-3.
39. Hiral S. Popaniya, Dinesh K. Danger, stimulation quatiification of Dapagliflozin and Linagliptin in pharmaceutical formulation: A stability-indicating RP-HPLC approach, International Journal of Bilogy, Pharmacy and Allied Sciences (IJHBPAS), January, 2026; 15(1): 416-428.
40. Priyabarbude, mukundtawar, Prashant Burange. Method Development using a UV Visible Spectrophotometer for the Simultaneous Estimation of Metformin (MET), Saxagliptin (SXG), and Dapagliflozin (DGF) in Marketed Formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(4): 243-7. Doi: 10.52711/2231-5675.2022.00039
41. Amanlou M, Zarei-Ghobadi M, Rofouei MK, Saremi S, Kebriaeezadeh A. Extractive Spectrophotometric Method for Determination of Pioglitazone Hydrochloride in Raw Material and Tablets Using Ion‐Pair Formation. Journal of Chemistry. 2010; 7(3): 915-21.
42. Mahadik SP, Senthilkumar GP. Method development & validation of pioglitazone in bulk and pharmaceutical dosage forms by using spectrophotometric method. Asian J. Biochem. Pharm. Res. 2012; 2: 159-65.
43. Ali MY, Swamy PV, Borgaonkar PR, Raju SA. UV-spectrophotometric determination of pioglitazone in pharmaceutical dosage forms. Int. J. Chem. Sci. 2008; 6(4): 2062-5.
44. Shakya P, Singh K. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by UV spectrophotometric method. International Journal of Pharmaceutical Sciences and Research. 2010; 1(11): 153.
45. Shakya P, Singh K. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by UV spectrophotometric method. International Journal of Pharmaceutical Sciences and Research. 2010; 1(11): 153.
46. Singh SC, Kushnoor A. Development and validation of a HPTLC method for estimation of pioglitazone in bulk and tablet dosage form. J Pharm Res. 2011; 4(11): 3919-21.
47. Ramulu K, Kumar TT, Krishna SR, Vasudev R, Kaviraj M, Rao BM, Rao NS. Identification, isolation and characterization of potential degradation products in pioglitazone hydrochloride drug substance. Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2010; 65(3): 162-8.
48. Ramulu K, Kumar TT, Krishna SR, Vasudev R, Kaviraj M, Rao BM, Rao NS. Identification, isolation and characterization of potential degradation products in pioglitazone hydrochloride drug substance. Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2010; 65(3): 162-8.
49. Sharma S, Sharma MC, Chaturvedi SC. Study of stressed degradation behavior of pioglitazone hydrochloride in bulk and pharmaceutical formulation by HPLC assay method. Journal of Optoelectronics and Biomedical Materials. 2010; 1(1): 17-24.
50. Varma. D. S., Dighe P. R.. Analytical Methods of Antidiabetic Drugs – Sitagliptin, Saxagliptin, Linagliptin, Alogliptin, Gemifibrozil, Troglitazone, Pioglitazone and Rosiglitazone: A Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2022; 14(4): 324-0.
51. M Yashpal Naidu, K P Channa Basavaraj, T Tamizh Mani, K Roopa. Validated RP-HPLC Method for the Quantitation of Pioglitazone an Anti - Diabetic Drug in Bulk and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2010; 3(3): 885-887.
52. Ramulu K, Kumar TT, Krishna SR, Vasudev R, Kaviraj M, Rao BM, Rao NS. Identification, isolation and characterization of potential degradation products in pioglitazone hydrochloride drug substance. Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2010; 65(3): 162-8.
53. Deepa P, Laxmanbhai P, Madhabhai P, Advaita PB. Simultaneous estimation of glimepiride, pioglitazone HCl and metformin HCl by derivative spectrophotometry method. Int. Res. J. Pharm. 2011; 2: 111-4.
54. Game MD. First order derivative spectrophotometric method for simultaneous estimation of glimepiride and pioglitazone HCl in combined dosage form. J. Pharm. Res. 2011; 4(11).
55. Sonali D. Rathod, P.M. Patil, S. B. Jadhav, P.D. Chaudhari. UV Spectrophotometric Simultaneous Determination of Metformin Hydrochloride and Pioglitazone Hydrochloride in Combined Dosage Form. Asian J. Pharm. Ana. 2012; 2(1): 05-09.
56. Ajow Swapna*, Chandaka Madhu, Mallepelli Srivani, M. Sumalatha, Y. Nehalatha, Y. Anusha analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(3): 85-89.
57. B. Venkateswara Rao, P. Vijetha, S. Vidyadhara, K. Kavitha. A Novel RP-HPLC Method Development and Validation for the Determination of Pioglitazone and Glimepiride in Bulk and Pharmaceutical Formulations. Asian J. Pharm. Ana. 2017; 7(3): 145-150.
58. Kapil Rana, Pushpendra Sharma. Development and Validation of a HPLC method for the Determination of Metformin hydrochloride, Nateglinide and Pioglitazone hydrochloride in Multicomponent Formulation. Asian J. Research Chem. 2021; 14(1): 7-12.
59. Ismail, R Rajavel, M Ganesh, M Jagadeeswaran, K Srinivasan, J Valarmathi, T Sivakumar. RP-HPLC Method for the Simultaneous Determination of Aspirin, Atorvastatin and Pioglitazone in Capsule Dosage Form. Asian J. Research Chem. 2008; 1(1): 40-42.
60. Varma. D. S., Dighe P. R.. Analytical Methods of Antidiabetic Drugs – Sitagliptin, Saxagliptin, Linagliptin, Alogliptin, Gemifibrozil, Troglitazone, Pioglitazone and Rosiglitazone: A Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2022; 14(4): 324-0.
61. Karthik A, Subramanian G, Rao CM, Bhat K, Ranjithkumar A, Musmade P, Surulivelrajan M, Karthikeyan K, Udupa N. Simultaneous determination of pioglitazone and glimepiride in bulk drug and pharmaceutical dosage form by RP-HPLC method. Pakistan journal of pharmaceutical sciences. 2008 Oct 1; 21(4).
62. Elzayat EM, Sherif AY, Attwa MW, Altamimi MA. A Green Approach: Optimization of the UPLC Method Using DoE Software for Concurrent Quantification of Pioglitazone and Dapagliflozin in a SNEDDS Formulation for the Treatment of Diabetes. ACS omega. 2024; 9(45): 45011.
63. Mr Tarang P, Ronak P. Method development, validation and forced degradation studies of Dapagliflozin and pioglitazone hydrochlorides in synthetic mixtures by RP-HPLC. International Journal of Trend in Scientific Research and Development. 2022; 6(6): 1858-69