Author(s): Avani N. Doshi, Vidhi Kotadiya, Isha R. Mishra

Email(s): avanidoshi20211@gmail.com

DOI: 10.52711/2231-5713.2026.00048   

Address: Avani N. Doshi1*, Vidhi Kotadiya2, Isha R. Mishra3
1HOD & Professor of Pharmaceutical QA/Chemistry, K. B. Raval College of Pharmacy, Gandhinagar, Gujarat, India. ORCIDs: 0000-0002-9959-2039
2Associate Professor of Pharmaceutical QA/Chemistry K. B. Raval College of Pharmacy, Gandhinagar, Gujarat, India. ORCIDs: 0009-0005-5098-3433
3Research Scholar, K. B. Raval College of Pharmacy, Gandhinagar, Gujarat, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 4,     Year - 2026


ABSTRACT:
A simple, rapid, economical, precise, and accurate stability-indicating RP-HPLC method for estimating ticagrelor and Aspirin in a synthetic mixture has been developed. A reverse phase high-performance liquid chromatographic method was developed for the estimation of Ticagrelor and Aspirin in a synthetic mixture has been developed. The separation was achieved using Waters Symmetry C18 (150mm × 4.6mm × 5µ), Phosphate buffer (pH 7.5) and methanol as mobile phase, at a flow rate of 1.0ml/min. Detection was carried out at 215nm, and retention times of Ticagrelor and Aspirin were found to be 3.853 and 6.829min. The method has been validated for linearity, accuracy, and precision. Linearity observed for Ticagrelor and Aspirin 45 – 135 µg/ml. The developed method was found to be accurate, precise, and rapid for estimating ticagrelor and Aspirin in a synthetic mixture. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and Thermal degradation under the same chromatographic conditions. The stress samples were assayed on RP-HPLC system.


Cite this article:
Avani N. Doshi, Vidhi Kotadiya, Isha R. Mishra. The Research Article on Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Ticagrelor and Aspirin in Synthetic Mixture. Asian Journal of Pharmacy and Technology. 2026; 16(4):344-0. doi: 10.52711/2231-5713.2026.00048

Cite(Electronic):
Avani N. Doshi, Vidhi Kotadiya, Isha R. Mishra. The Research Article on Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Ticagrelor and Aspirin in Synthetic Mixture. Asian Journal of Pharmacy and Technology. 2026; 16(4):344-0. doi: 10.52711/2231-5713.2026.00048   Available on: https://www.ajptonline.com/AbstractView.aspx?PID=2026-16-4-3


REFERENCES:
1.    Drug Bank/Ticagrelor, November 24, 2024, https://go.drugbank.com/drugs/DB06624
2.    PubChem Ticagrelor, October 2021, https://pubmed.ncbi.nlm.nih.gov/35396017/
3.    Drug Bank/Aspirin https://go.drugbank.com/drugs/DB00945 
4.    PubChem/Aspirin, https://pubchem.ncbi.nlm.nih.gov/compound/ Aspirin
5.    International Conference on Harmonization, ICH guidelines Q1A (R2). Stability Testing of New Drug Substances and Products 
6.    Carr, G. P., and Wahlich, J. C. A practical approach to method validation in pharmaceutical analysis. Journal of Pharmaceutical and Biomedical Analysis. 1990; 8(12): 613-618. 
7.    IPC/GD/04, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, 16th September 2021
8.    International conference on harmonization, ICH harmonised tripartite guideline stability testing of new drug substances and products Q1A(R2) current step 4 version dated 6 february 2003.
9.    ICH harmonised tripartite guideline impurities in new drug substances Q3A(R2) current step 4 version dated 25 october 2006
10.    International Conference on Harmonization, ICH Q2R2, Validation of Analytical Procedures, Text and Methodology
11.    Joshy E, Babu A, D’Cruz D, TP A. Development and validation of RP-HPLC method for determination of ticagrelor in pharmaceutical dosage formulation. Der Pharmacia Lettre. 2016; 8(9): 206–212. 
12.    D’Cruz D, Babu A, Joshy E, T P A. Bioanalytical method development and validation of ticagrelor by RP-HPLC. Int J Appl Pharm. 2017; 9(3): 51–4
13.    Tabassum K, Sarvesh R. Analytical method development and validation studies of ticagrelor tablets by RP-HPLC. Int J Appl Pharm. 2017; 9(4): 10–21.
14.    Shyamalambica P, Vijaya Lakshmi M. Development and validation of stability indicating RP-HPLC method for the estimation of ticagrelor in formulation. Int J Eng Res Technol. 2018; 7(10): 81.
15.    Ravisankar P, Prasada Rao CV, Gunturu SK, Srinivasa Babu P, Navya P, Nayak MT. Development and validation of RP-HPLC method for the determination of ticagrelor (an antiplatelet agent) in pharmaceutical dosage form. July 2021 
16.    Parida AK, Rao KS, Patnaik AK. A novel validated RP-HPLC method for the estimation of ticagrelor in bulk and pharmaceutical dosage forms. Res J Pharm Technol. 2018; 11(3): 1019-1024. 
17.    Gobetti C, Lazzaretti Pereira R, Loureiro Mendez AS, Garcia CV. Determination of the new antiplatelet agent ticagrelor in tablets by stability-indicating HPLC method. Curr Pharm Anal. 2014; 10(4): 279-83.
18.    Bairam R, Tatapudi HK, Gajji N, Rasheed SH. UV spectrophotometric and HPLC method for quantification of ticagrelor in bulk and tablet dosage form. Asian J Pharm Anal. 2022; 12(3): 159-65.
19.    Eswarudu MM, Rao AL, Vijay K. Bioanalytical RP-HPLC method for simultaneous quantification of rivaroxaban and ticagrelor in spiked human plasma: Validation and stability. Res J Pharm Technol. 2023; 16(6): 2741-6.
20.    Kamal AH, Marie AA, Hammad SF. Stability indicating RP-HPLC method for simultaneous determination of omeprazole and aspirin in the presence of salicylic acid as degradation product. Microchem J. 2020; 152: 104350.
21.    Gousuddin M, Sengupta P, Tripathi VD, Das A. Stability indicating RP-HPLC method for simultaneous determination of aspirin and clopidogrel in dosage form. Malays J Anal Sci. 2016; 20(2): 247–57.
22.    Pisal P, Nigade GA, Kale AM, Pawar SM. Development and validation of stability indicating RP-HPLC method for simultaneous determination of aspirin, rosuvastatin, clopidogrel in bulk and pharmaceutical dosage form. Int J Pharm Pharm Sci. 2018; 10(10): 50-56.
23.    Reddy PS, Sudhakar Babu K, Kumar N. Development and validation of a stability-indicating RP-HPLC method for the simultaneous estimation of process related impurities and degradation products of rasagiline mesylate in pharmaceutical formulation. J Chromatogr Sci. 2013; 51(3): 242–9.
24.    Hammud HH, El Yazbib FA, Mahrous ME, Sonji GM, Sonji NM. Stability-indicating spectrofluorimetric and RP-HPLC methods for the determination of aspirin and dipyridamole in their combination. The Open Spectroscopy Journal. 2008; 2(1): 19–28.
25.    Sherikar O, Mehta P. Comprehensive assessment of degradation behavior of aspirin and atorvastatin singly and in combination by using a validated RP-HPLC method. Sci Pharm. 2013 Jan-Mar; 81(1): 195–210. doi: 10.3797/scipharm.1210-19.
26.    Patel SM, Patel CN, Patel VB. Stability-indicating HPLC method for simultaneous determination of aspirin and prasugrel. Indian J Pharm Sci. 2013; 75(4): 413–9.
27.    Devaka NVS, Parepalli Y, Rao VM. Stability indicating RP-HPLC method for simultaneous estimation of aspirin and prasugrel in combination capsule dosage. Res J Pharm Technol. 2021; 14(3): 1365-1369.
28.    Karnik KS, Pingle AP, Jadhav A. Development and validation of stability-indicating RP-HPLC method for simultaneous estimation of ramipril, atorvastatin calcium and aspirin in a combined capsule dosage form. World J Pharm Res. 2015; 4(7): 1612-25.
29.    Vidhi Dave, P. U. Patel. Analytical QbD Assisted RP- HPLC Method Development and Validation for Estimation of Anti-diabetic Drug Remogliflozin in Bulk and its Pharmaceutical Dosage form. Research Journal of Pharmacy and Technology. 2025; 18(7): 3244-9. doi: 10.52711/0974-360X.2025.00467
30.    Dave Vidhi, Paresh Patel. Method development and Validation of UV Spectrophotometric estimation of Remogliflozin Etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021; 14(4): 2042-4. doi: 10.52711/0974-360X.2021.00362.

Recomonded Articles:

Author(s): Ruchika Sharma, M. S. Ashawat, C. P. S Verma, Neha Kumari

DOI: 10.5958/2231-5713.2020.00039.2         Access: Open Access Read More

Author(s): Chinmaya Keshari Sahoo, K. Satyanarayana, D. Venkata Ramana, Kanhu Charan Panda

DOI: 10.5958/2231-5713.2017.00034.4         Access: Open Access Read More

Author(s): Mounika P Siridevi, Hemant T Kumar, Srinivasa Y Rao, Vara Prasad K Rao

DOI: 10.5958/2231-5713.2019.00035.7         Access: Open Access Read More

Author(s): Shamali Dange, Ravindra Jadhav, Sunayana Vikhe

DOI: 10.52711/2231-5713.2022.00004         Access: Open Access Read More

Author(s): Abdul Saleem Mohammad, Swetha Devidi, Nikhat Fatima, Humera Badar, Syeda Saba Sulthana, Mohammad Akthar Sulthana, Nuha Rasheed

DOI:         Access: Open Access Read More

Author(s): S. Kathirvel, R. Raju, B. Seethadevi, A. Suneetha, J. Pavani

DOI:         Access: Open Access Read More

Author(s): Sayali S. More, Sandeep S. Sonawane, Santosh S. Chhajed, Sanjay J. Kshirsagar

DOI: 10.5958/2231-5713.2018.00023.5         Access: Open Access Read More

Author(s): Ashwini Shelke, Madhavi Shinde, Rajendra Mogal, Rahul Sable, Anil Jadhav

DOI: 10.5958/2231-5713.2018.00016.8         Access: Open Access Read More

Author(s): Prajakta M. Patil, Omprasad S. Nayakal, Mangesh Bhutkar, Somnath Bhinge, Dheeraj Randive

DOI: 10.5958/2231-5713.2018.00018.1         Access: Open Access Read More

Author(s): S. Rawat, Akhilesh Gupta

DOI:         Access: Open Access Read More

Author(s): P. Swathi, K. Rajeswar Dutt, K. N. V Rao, M. Alagar Raja

DOI: 10.5958/2231-5713.2017.00025.3         Access: Open Access Read More

Author(s): Tentu Nageswara Rao, A. Vijayalakshmi, Karri Apparao, N. Krishnarao

DOI: 10.5958/2231-5713.2017.00024.1         Access: Open Access Read More

Author(s): Anjaneyulu.Vinukonda, K. B. Chandra Sekhar, Shaik Muneer, B. Siva Sai Kiran, Akkimi Padma, Pallavi A

DOI: 10.5958/2231-5713.2019.00002.3         Access: Open Access Read More

Asian Journal of Pharmacy and Technology (AJPTech.) is an international, peer-reviewed journal, devoted to pharmaceutical sciences...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5713 


Journal Policies & Information




Recent Articles




Tags