Author(s):
Mitali Dalwadi, Jinal Patel, Suraj Singh, Krina Patel
Email(s):
mitaliswami7@gmail.com , jinalpatel3862@gmail.com , 7048261046s@gmail.com , krinapatel1674@gmail.com
DOI:
10.52711/0974-360X.2026.00522 
Address:
Mitali Dalwadi1, Jinal Patel2, Suraj Singh3, Krina Patel4
1Assistant Professor, Department of Quality Assurance, Sigma Institute of Pharmacy, Sigma University, Vadodara, Gujrat, India.
2Student, Sigma Institute of Pharmacy, Sigma University, Vadodara, Gujarat, India.
3Assistant Professor, Department of Quality Assurance, Sigma University, Vadodara, Gujarat, India.
4Student, Sigma Institute of Pharmacy, Sigma University, Vadodara, Gujarat, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 8,
Year - 2026
ABSTRACT:
Azelnidipine and Telmisartan, two hypertension medications, were simultaneously quantified using an HPLC approach that was sensitive, accurate, and repeatable. Using an isocratic elution mode and a mobile phase made up of methanol, ACN, and phosphate buffer (pH5.0), chromatographic separation was accomplished. (50:30:20%v/v/v) on a C18 column with a 1.0ml/min flow rate. The ideal sensitivity for both analytes was ensured by doing the detection at 254nm. With a correlation coefficient (r2 > 0.999), the approach showed excellent linearity for both telmisartan and azelnidipine throughout a concentration range of 25–150µg/ml. The precision, accuracy, specificity, robustness, and system adaptability of the approach were confirmed by validation studies carried out in accordance with ICH Q2(R1) recommendations. Reproducibility was proven by intra- and inter-day precision (%RSD < 2%) and recovery experiments showed great accuracy (98–102%). The technique held up well against slight changes in the pH, flow velocity, and content of the mobile phase. For routine quality control analysis of mixed Azelnidipine and Telmisartan tablet formulations, this validated HPLC method provides an easy, quick, and dependable option.
Cite this article:
Mitali Dalwadi, Jinal Patel, Suraj Singh, Krina Patel. RP-HPLC Method Development and Validation for Simultaneous Determination of Azelnidipine and Telmisartan in Tablet Formulation. Research Journal of Pharmacy and Technology. 2026;19(8):3699-6. doi: 10.52711/0974-360X.2026.00522
Cite(Electronic):
Mitali Dalwadi, Jinal Patel, Suraj Singh, Krina Patel. RP-HPLC Method Development and Validation for Simultaneous Determination of Azelnidipine and Telmisartan in Tablet Formulation. Research Journal of Pharmacy and Technology. 2026;19(8):3699-6. doi: 10.52711/0974-360X.2026.00522 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-8-39
REFERENCES:
1. Rabadiya VA, Shah N, Akabari AH. A Novel Stability-Indicating HPLC Method with Kinetics Study for the Concurrent Analysis of Anti-Hypertensive Drug Combination of Atenolol and Indapamide. Drug Metabolism and Bioanalysis Letters. 2025; 18(1): 54-70. http://dx.doi.org/10.2174/0118723128346156250217055422
2. Vibhuti AR, Nehal S, Ashok AH, "Eco-Friendly RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Indapamide: Analytical Quality by Design Approach and Greenness Assessment" separation science plus, 2025, 8(3), e70019 https://doi.org/10.1002/sscp.70019
3. Akabari AH, Solanki DK, Patel SK, Desai P, Jainisha G, Patel B, et al. Development and validation of a novel simultaneous equation and Q-absorbance ratio method for the quantitative estimation of atenolol and hydrochlorothiazide in combined tablet dosage forms: A green analytical chemistry approach. Green Analytical Chemistry. 2025 Mar; 12: 100224. 10.1016/j.greeac.2025.10022.
4. Wikipedia contributors. Azelnidipine [Internet]. Wikipedia, The Free Encyclopedia. Available from: https://en.wikipedia.org/wiki/Azelnidipine
5. Anna JB, Lesley S. Telmisartan: a review of its use in the management of hypertension. Drugs. 2006; 66(1): 51-83. https://doi.org/10.2165/00003495-200666010-00004
6. Gore MG, Dabhade PS. RP-HPLC method development and validation of azelnidipine. Int J Pharm Sci Res. 2016; 7(12): 5111-4. 10.13040/IJPSR.0975-8232.7(12).5111-14
7. Vishal U. Shewale, Smita S. Aher, Dr. Ravindranath B. Saudagar. Azelnidipine: a review on therapeutic role in hypertension. J Drug Deliv Ther. 2019; 9(3s): 1002-5. https://doi.org/10.22270/jddt.v9i3-s.3090
8. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Validation of analytical procedures: text and methodology Q2(R1) [Internet]. Available From: https://www.ich.org/page/quality-guidelines
9. Jadhav RS. UV spectrophotometric analytical method development and validation for determination of telmisartan in pharmaceutical drug and drug product (tablet dosage form). Int J Curr Adv Res. 2018; 7(6): 13292-6. http://dx.doi.org/10.24327/ijcar.2018.13296.2363
10. Chivate ND, Gaviraj EN, Chivate ND. Development of UV spectrophotometric method for estimation and validation of telmisartan as a pure API. J Pharm Res. 2012; 5(6): 3331-3.
11. Sonali D. Rathod, P. M. Patil, P. D. Chaudhari UV-spectrophotometric method for estimation of telmisartan in bulk and tablet dosage form. Int J ChemTech Res. 2012; 3(10): 3936-39. http://dx.doi.org/10.13040/IJPSR.0975-8232.3(10).3936-39
12. Kunti D Rasakpur, Mrunali MP, Anand kumari DC. Dissolution method development and validation for tablet dosage form of telmisartan using UV spectrophotometric method. J Chem Pharm Res. 2018; 10(5): 148-56.
13. Komal Patel, Amit Patel, Chaganbhai Patel. Stress degradation studies on telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms. Pharm Methods. 2011; 2(4): 253-9. https://doi.org/10.4103/2229-4708.93396
14. Jawla S, Gupta AK, Singla R, Gupta V. Development and validation of simultaneous HPLC method for estimation of telmisartan and ramipril in pharmaceutical formulations. Int J PharmTech Res. 2010; 2(2): 1625-31.
15. Sinha SK, Prabhat K.S., Sushant K.S. Development and validation of an HPLC method for the simultaneous estimation of amlodipine and telmisartan in pharmaceutical dosage form. Asian Pac J Trop Biomed. 2012; 2(1): 312-5. https://doi.org/10.1016/S2221-1691(12)60180-4
16. P. Ashok, S.T. Narendran, S.N. Meyyanathan, B. Babu Development and validation of an RP-HPLC method for estimation of telmisartan in human plasma. Int J Appl Pharm. 2019; 11(1): 237-40. https://doi.org/10.22159/ijap.2019v11i1.30513
17. Bhaskara Raju V, Bonthu Mohan Gandhi RP-HPLC method development and validation for simultaneous estimation of telmisartan and ramipril in pure and pharmaceutical dosage forms. Asian J Res Chem. 2017; 10(2): 174-8. https://doi.org/10.5958/0974-4150.2017.00030.X
18. Tomlesh kumar BD, Sujata S. Deo, Farhin S. Development and validation of novel HPTLC method for the simultaneous estimation of amlodipine besylate and telmisartan in tablet dosage form using ICH Q2 (R1) directions. J Chin Adv Mater Soc. 2018; 6(4): 329-40. https://doi.org/10.1080/22243682.2018.1425905
19. Heta K, Jinal Tandel, Adit Velani, Suchi Patel, Krupa Patel. Development and validation of HPTLC method for simultaneous estimation of azelnidipine and telmisartan. J Adv Drug Discov Dev. 2023; 1(1): 28-38.
20. Imdad HM, Qureshi S, Khan S. Analytical method development and validation of azelnidipine by UV-visible spectroscopy. World J Pharm Res. 2021; 10(10): 858-72. https://doi.org/10.20959/wjpr202110-21174
21. Suthar P, Patel V, Desai N. Advanced UV spectrophotometric method development and validation for simultaneous estimation of azelnidipine and telmisartan in pharmaceutical dosage form. Indian J Pharm Drug Stud. 2023; 2(1): 27-32. https://mansapublishers.com/ijpds/article/view/3602
22. Raskapur KD, Patel PN, Shah DA. UV-spectrophotometric method development and validation for determination of azelnidipine in pharmaceutical dosage form. Int J Pharm Pharm Sci. 2011;3(3):238-40.
23. Rele RV. Spectrophotometric estimation of azelnidipine in bulk drug and pharmaceutical dosage form by first order derivative and area under curve methods. Am J PharmTech Res. 2014; 4(2): 126-35.
24. Peddi P, Awasthi R, Reddy N. A validated stability indicating RP-HPLC method for determination of azelnidipine and its impurities in pharmaceutical formulation. Indian Drugs. 2020; 57(8): 36-44. https://doi.org/10.53879/id.57.08.12061
25. Akshay SR. Validation and forced stability-indicating HPTLC method for determination of azelnidipine. World J Pharm Res. 2016; 5(9): 1053-62.
26. Juhi Raimalani, Rajendra Kotadiya Separation and quantification of azelnidipine and chlorthalidone in a synthetic mixture using optimized HPTLC method. Ann Pharm Fr. 2024; 82(1): 53-63. https://doi.org/10.1016/j.pharma.2023.07.008
27. Prabhu C, Subramanian GS, Karthik A. Determination of telmisartan by HPTLC – a stability indicating assay. J Planar Chromatogr. 2007; 20(6): 77-81.https://doi.org/10.1556/JPC.20.2007.6.14
28. Panda M, Dadi V, Yarraguntla SR, Rao VP. RP-HPLC method for determination of azelnidipine and telmisartan in pharmaceutical dosage form. Res J Pharm Technol. 2023; 16(2): 509-13. https://doi.org/10.52711/0974-360X.2023.00086
29. Dinakaran V, Unnissa SH. Development and validation of an RP-HPLC method for the simultaneous estimation of azelnidipine and telmisartan in pharmaceutical tablet dosage form. Res J Pharm Technol. 2023; 16(6): 2638-42.https://doi.org/10.52711/0974-360X.2023.00433
30. Manish k, Umesh Chandra, Aun Garg, Pankaj Gupta. A stability indicating RP-HPLC method validation for simultaneous estimation of azelnidipine and telmisartan in a fixed-dose combination. Int J Pharm Sci Drug Res. 2021; 13(3): 288-94. https://doi.org/10.25004/IJPSDR.2021.130308
31. D. Basava Chaitanya, M. Ajitha. Stability Indicating RP-HPLC Method Development and Validation for simultaneous estimation of Azelnidipine and Telmisartan in Bulk and Pharmaceutical Dosage Form World Journal of Pharmaceutical Science. 2022; 10(01): 121-127. https://doi.org/10.54037/WJPS.2022.100113