Author(s): Shakeel Memon, Neha Mohite, Kanchan Chauhan, Tabssum Hangad, Dilnawaz Pathan

Email(s): memon.shakeel@gmail.com

DOI: 10.52711/0974-360X.2026.00231   

Address: Shakeel Memon1, Neha Mohite4*, Kanchan Chauhan1, Tabssum Hangad2, Dilnawaz Pathan3
1Associate Professor, M. C. E. Society’s Allana College of Pharmacy, Azam Campus, Pune, Maharashtra, India.
2Assistant Professor, M. C. E. Society’s Allana College of Pharmacy, Azam Campus, Pune, Maharashtra, India.
3HOD, Department of Pharmaceutics, Trinity College of Pharmacy, Pune, Maharashtra, India.
4Assistant Professor, Adarsh College of Pharmacy, Vita, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 19,      Issue - 4,     Year - 2026


ABSTRACT:
The analytical investigation work illustrates the expansion along with validation of a HPTLC chromatographic technology intended for instantaneous evaluation drugs, Dapagliflozin (DAPA) along with Vildagliptin (VILDA) within pharmaceutical formulation. Utilizing aluminum-backed TLC plates (10 × 10 ) already coated with 250µm layer of silica gel having pore size 60 with fluorescent indicator F254 while in mobile phase and a mobile phase made up of n-Hexane: EthylAcetate: Methanol (3:6:1 v/v/v), the chromatography was execute. By densitometrically scanning plates at 225nm and 243nm with Camag TLC scanner, the drug’s quantitative determination was carried out. The linearity with accuracy along with precision with that detection limit and quantitation limit of as well as robustness of established technique approach was every confirmed. By employing an ultraviolet detector with a wavelength of 225 and 243 nm, DAPA and VILDA were quantified using this method respectively. With supplementary peaks at Rf values of 0.44±0.12 and 0.72±0.23 for DAPA and VILDA correspondingly, both drugs demonstrated deterioration.


Cite this article:
Shakeel Memon, Neha Mohite, Kanchan Chauhan, Tabssum Hangad, Dilnawaz Pathan. Development and Validation of a HPTLC Method to Estimate Dapagliflozin and Vildagliptinalong with Bulk and Marketed Formulation. Research Journal of Pharmacy and Technology. 2026;19(4):1618-4. doi: 10.52711/0974-360X.2026.00231

Cite(Electronic):
Shakeel Memon, Neha Mohite, Kanchan Chauhan, Tabssum Hangad, Dilnawaz Pathan. Development and Validation of a HPTLC Method to Estimate Dapagliflozin and Vildagliptinalong with Bulk and Marketed Formulation. Research Journal of Pharmacy and Technology. 2026;19(4):1618-4. doi: 10.52711/0974-360X.2026.00231   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-4-20


REFERENCE:
1.    Merugu Manasa, Vijey Aanandhi M. Stability Indicating Simultaneous Method development and Validation of Dapagliflozin and Saxagliptin by RP-HPLC. Research J. Pharm. and Tech. 2021; 14(2): 1045-1049. doi: 10.5958/0974-360X.2021.00187.6
2.    Ashok B. Patel et al. Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC. Research Journal of Pharmacy and Technology. 2021; 14(9): 4635-9. doi: 10.52711/0974-360X.2021.00805
3.    Rama Kumar Kandula, Raja Sundararajan. Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(11): 5813-8. doi: 10.52711/0974-360X.2021.01011
4.    Amitkumar J. Vyas, et al. Diode Array Detector Based RP-UPLC Method for Simultaneous Estimation of DapagliflozinPropanediol Monohydrate and Metformin. Research Journal of Pharmacy and Technology. 2024; 17(3): 991-996 doi: 10.52711/0974-360X.2024.00153
5.    Ravi Sankar Erukulapati et al. Real-life Comparison of the Efficacy and Safety of Vildagliptin vs Dapagliflozin as add-on-Drug Therapy to Metformin Alone or Metformin and Sulfonylureas Combination in People with Type 2 Diabetes. Research Journal of Pharmacy and Technology. 2024; 17(9): 4347-2. doi: 10.52711/0974-360X.2024.00672
6.    Sujan Banik, Palash Karmakar and Md. Anowar Hossain Miah. Development and Validation ofa UV-Spectrophotometric Method for Determination of Vildagliptin and Linagliptin in Bulkand Pharmaceutical Dosage Forms. Bangladesh Pharmaceutical Journal, 2015; 18(2): 163-168.
7.    Sanagapati Manasa et al. Method Development and Validation of Dapagliflozin in API by RP-HPLC and UV-Spectroscopy. Int. J. Pharm. Sci. Drug Res. 2014; 6(3): 250-252.
8.    K. R. Patil, T. A. Deshmukh and V. R. Patil. A stability indicating hptlc method development and validation for analysis of vildagliptin as bulk drug and from its pharmaceutical dosage form. LJPSR. 2020; 11(5): 2310-2316.
9.    Sruthi K, et al. Development of Validated HPTLC Method for Simultaneous Estimation of Fexofenadine Hydrochloride and Montelukast Sodium in Tablet Dosage form. Research J. Pharm. and Tech. 2016; 9(4): 469-473. doi: 10.5958/0974-360X.2016.00087.1
10.    Sagar B. Wankhede, Deepak S. Khobragade, Sukeshini B. Lote, S. Patil. Stability Indicating HPTLC Method for Simultaneous Determination of Amlodipine Besylate and Lisinopril in Combined Dose Tablet Formulation. Research Journal of Pharmacy and Technology. 2021; 14(12): 6250-6. doi: 10.52711/0974-360X.2021.01081
11.    Kalyani U. Et al. Stability indicating HPTLC method development and validation for the estimation of celecoxib in bulk drug and its Pharmaceutical formulation. Research J. Pharm. and Tech. 2020; 13(8): 3661-3665. doi: 10.5958/0974-360X.2020.00647.2
12.    N. Tamilselvi, R. Arivukkarasu, Sasikala R, Shahanas, Shamina, SreelakshmiJayan. Development and Validation of HPTLC method for the Determination of Efavirenz in Tablet Dosage Form. Research J. Pharm. and Tech. 2018; 11(3): 885-888. doi: 10.5958/0974-360X.2018.00169.5
13.    Amber Vyas et al. HPTLC Method Development of Herbal drugs and its Validation: An Overview. Research Journal of Pharmacy and Technology. 2023; 16(8): 3964-6. doi: 10.52711/0974-360X.2023.00652.
14.    Mrs. Aishwarya P. Joglekar. Method Development and Validation for the Estimation of Telmisartan and Chlorthalidone in Bulk and Pharmaceutical Dosage form by HPTLC Method. Research J. Pharm. and Tech. 2015; 8(4): 376-381. doi: 10.5958/0974-360X.2015.00063.3
15.    Santosh R. Butle, Padmanabh B.  Deshpande. Validated stability-indicating  HPTLC method  development for determination of vildagliptin as bulk drug and in tablet dosage form. European Journal of Pharmaceutical and Medical Research. 2015; 2(6): 234-237
16.    Sopan N. Kharat, Nida Ansari, Vijay D. Mendhulkar. HPTLC screening for Flavonoids content in leaf extracts of Syzygiumcumini (Linn.) and its Antimicrobial activity. Research J. Pharm. and Tech. 2020; 13(6): 2720-2726. doi: 10.5958/0974-360X.2020.00484.9
17.    S. J. Daharwal, Suman Shrivastava. HPTLC Method Development and Validation for Quantification of Quercetin in Thujaoccidentalis Mother tincture. Research J. Pharm. and Tech. 2019; 12(9): 4102-4106. doi: 10.5958/0974-360X.2019.00707.8
18.    Shubhangi V. Sutar, Veerendra C. Yeligar. Degradation Kinetic Study of Melatonin in Alkaline and Acidic Medium by Validated Stability Indicating HPTLC Method. Research J. Pharm. and Tech 2020; 13(2): 523-528. doi: 10.5958/0974-360X.2020.00099.2
19.    Kavitha J et al. Validated HPTLC Method for the Estimation of Oxetacaine in Pharmaceutical Formulations. Research Journal of Pharmacy and Technology. 2021; 14(11): 5668-2. doi: 10.52711/0974-360X.2021.00985
20.    Mohammed Aabid et al. Development and Validation of a UV Spectroscopic Method to Estimate EltrombopagOlamine along with Bulk and In-house Formulation. Research Journal of Pharmacy and Technology. 2023; 16(11): 5010-4. doi: 10.52711/0974-360X.2023.00811
21.    V. Jain, et al. HPTLC method for routine quality control of Ayurvedic formulation Drakshadigutika. Asian J. Pharm. Ana. 2013; 3(4):  111-114.
22.    A.K. Desai, et al. HPTLC Method for the Simultaneous Estimation of Amlodipine Besylate and Indapamide in Tablet Formulation. Asian J. Research Chem. 2012; 5(4):  510-514.
23.    Savita S Yadav, Janhavi R Rao. Spectrophotometric estimation of Nebivolol hydrochloride and HPTLC method for simultaneous determination of Nebivolol hydrochloride and Hydrochlorothiazide in bulk drug and in pharmaceutical formulation. Asian J. Research Chem. 2012; 5(5):  576-581.
24.    Santhi N, et al. Simultaneous Estimation of Cefixime and Ofloxacin in Bulk and Tablet Dosage Form. Asian J. Pharm. Ana.2011; 1(3):  50-52.
25.    TentuNageswara Rao, A. Vijayalakshmi, Karri Apparao, N. Krishnarao. A New Analytical Method Validation and Quantification of OlmesartanMedoxomil and its related impurities in bulk drug product by HPLC. Asian J. Pharm. Tech. 2017; 7 (3): 147-152.
26.    Rabindra K Nanda et al. A Stability-indicating HPTLC method for estimation of Nadifloxacin in topical cream. Res. J. Topical and Cosmetic Sci. 2010; 1(1):  25-29.


Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.52711/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available