Author(s):
Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed
Email(s):
hemkar_pharma@yahoo.co.in
DOI:
10.52711/2231-5675.2022.00027 
Address:
Ravinder Bairam1, Hemant Kumar Tatapudi1, Neelama Gajji2, Shaik Harun Rasheed3
1Department of Pharmaceutical Analysis, Srikrupa Institute of Pharmaceutical Sciences, Siddipet-502 277 (TS), India.
2Department of Pharmacognosy, Srikrupa Institute of Pharmaceutical Sciences, Siddipet-502 277 (TS), India.
3Department of Pharmaceutics, Gurunanak Institute of Pharmacy, Khanapur, Telangana 501506 India.
*Corresponding Author
Published In:
Volume - 12,
Issue - 3,
Year - 2022
ABSTRACT:
The aim of the present investigation was to develop, validate and compare a UV spectrophotometric and a high performance liquid chromatography method for estimating Ticagrelor in bulk and tablet dosage form. Spectrophotometry and high performance liquid chromatography were carried out using standard instrumental parameters, which were optimized. Both methods were validated in terms of linearity, accuracy, precision, robustness, ruggedness and stability according to the ICH guidelines. The optimized ratio of mobile phase in high performance liquid chromatography under low pressure gradient mode was 30:70 % v/v of acetonitrile:glacial acetic acid 1 % , which provide a sharp peak with a short retention time of 3.910 minutes. In UV spectrophotometric analysis iso-propyl alcohol as a solvent gave adequate molar absorptivity at a ?max of 306 nm. Results indicated that both UV spectrophotometric and high performance liquid chromatography methods were linear, precise, accurate, rugged and robust with RSD values less than 2 % and percent recovery was within the standard limits (90-110 %). Both the methods were found to be statistically non-significant at 95 % confidence intervals (p<0.05) with respect to each other. The proposed methods were found to be highly effective and could be used for quantification of Ticagrelor in bulk and a tablet formulations for routine analysis.
Cite this article:
Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed. UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):159-5. doi: 10.52711/2231-5675.2022.00027
Cite(Electronic):
Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed. UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):159-5. doi: 10.52711/2231-5675.2022.00027 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-3-1
REFERENCES:
1. Husted S, van Giezen JJ. Ticagrelor, the first reversibly binding oral P2Y12 receptor antagonist. Wiley Online Library. 259-274,1755-5922.
2. Anninos H, Koulouris S, Manolis AS. Ticagrelor: a novel P2Y12 platelet receptor antagonist—a review of its properties, pharmacology and clinical usefulness. Hospital Chronicles. 2010; 5 : 70–75.
3. Danielak D, Karaźniewicz Łada M, Główka F. Ticagrelor in modern cardiology—an upto date review of most important aspects of ticagrelor pharmacotherapy. Expert Opinion on Pharmacotherapy. 2018;19: 103–112.
4. M A Hakeem Siddiqui, Roshan S. Pharmacokinetic Drug Interactions between HMG-COA Reductase Inhibitors Fluvastatin with Concomitantly administered Ticagrelor. Research J. Pharm. and Tech. 2018; 11(1): 179-182
5. Gobetti C, Lazzaretti PR, Sebastian LA, Garcia VC. Determination of the new antiplatelet agent ticagrelor in tablets by stability-indicating HPLC method. Current Pharmaceutical Analysis. 2014; 10: 279–283.
6. Joshy E, Babu A , D'Cruz D, Aneesh, TP. Development and validation of RP- HPLC method for determination of ticagrelor in pharmaceutical dosage formulation. Der Pharmacia Lettre. 2016; 8 :206–212.
7. Kakde R.B, Satone DD, Dongare G, Chilbule R, Malkhede Y. Method development, validation and impurity profiling of ticagrelor by acid degradation method. International Journal of Pharm Tech Research. 2017; 10 :225–236.
8. Kaylani L, Lakshmana R. A validated stability-indicating HPLC method for the determination of ticagrelor in bulk and its formulations. International Journal of Pharmacy. 2013; 3: 634–642.
9. Tabassum K, Sarvesh R. Analytical method development and validation studies of ticagrelor tablets by RP-HPLC. International Journal of Applied Pharmacy. 2017; 9: 10–21.
10. Kulkarni PR, Gajare GK. Development and validation of RP-HPLC method for estimation of ticagrelor in bulk form. International Journal of Research in Pharmacy and Chemistry. 2016; 6(4):733-37.
11. Carem G, Pereira RL, Mendez ASL, Gaveia CV. Determination of new anti-platelet agent, Ticagrelor in tablet by stability indicating HPLC method, Bantham Science Publisher, Vol.10, 279-283,1573-4129.
12. Aswini Kumar Parida, K. Srinivasa Rao, Ajay Kumar Patnaik. A Novel Validated RP-HPLC Method for the estimation of Ticagrelor in Bulk and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2018; 11(3): 867-872.
13. D’Cruz D.; Babu A.; Joshy E.; Aneesh T. P. Bioanalytical method development and validation of ticagrelor by RP-HPLC. International Journal of Applied Pharmaceutics. 2017; 9(3):51-54.
14. Kumar N A, Swathi PN , Sharmila D, Sharmila S, Pawar AKM. . A validated stability indicating method of UVspectrophotometry for the estimation of ticagrelor in bulk and marketed formulation. Der Pharmacia Lettre. 2016; 8: 309–315.
15. Mrunal A, Ambasana, Naval P, Kapuriya, Nilkanth JF, Kartik DL. Development and validation of a UV spectrophotometric method for the determination of Ticagrelor in bulk form. J. Der Pharmacia Lettre. 2014;4: 237-240.
16. Oliveira SS, Bitencourt SA, Gobetti C, Mendez ASL, Garcia CV. Assaying the antiplatelet ticagrelor by validated UV spectrophotometric method with performance equivalent to HPLC. Current Pharmaceutical Analysis. 2017; 13: 538–542.
17. Pandya D , Pavel M., Ghediya R, Shah A, Khunt R. (2016). UV–vis spectrophotometric assay determination of oral antiplatelet ticagrelor drug in pharmaceutical formulation: Application to content uniformity. Journal of Chemical and Pharmaceutical Research. 2016; 8: 316–321.
18. Souri E, Hamid KM, Tehrani MB, Jalalizadeh H. Spectrophotometric methods for determination of ticagrelor in dosage forms. Asian Journal of Pharmacy and Pharmacology. 2017; 3: 172–176.
19. Peng J, Wang Y, Li, M, He C, Chen Y, Chen X, Tan, Z. An HPLC–MS/MS method for the quantitative determination of ticagrelor and its active metabolite ARC124910XX in human plasma and its application to a clinical study. Current Pharmaceutical Analysis. 2017;13 :296–303.
20. Kumar N, Devineni SR, Gajjala PR, Gupta DK, Bhat S, Kumar R, Kumar P. Four process-related potential new impurities in ticagrelor: identification, isolation, characterization using HPLC, LC/ESI–MSn, NMR and their synthesis. Journal of Pharmaceutical and Biomedical Analysis. 2016; 120: 248–260.
21. Sillen H, Cook M, Davis P. Determination of ticagrelor and two metabolites in plasma samples by liquid chromatography and mass spectrometry. Journal of Chromatography B. 2017;878: 2299–2306.
22. Sillen H, Cook M, Davis P. (2011). Determination of unbound ticagrelor and its active metabolite (ARC124910XX) in human plasma by equilibrium dialysis and LC–MS/MS. Journal of Chromatography B. 2011;879: 2315–2322.
23. Yaye SH, Secrétan PH, Henriet T, Bernard M, Amrani F, Akrout W, Do B. Identification of the major degradation pathways of ticagrelor. Journal of Pharmaceutical and Biomedical Analysis. 2015; 105:74–83.
24. Zhong W, Wang X, Tang L, Mai L, Chen XP, He G, Zhong Z. Simultaneous determination of ticagrelor and its metabolites in human plasma and urine using liquid chromatography–tandem mass spectrometry. Journal of Analytical Toxicology. 2016;40: 445–453.
25. Ambasana MA, Kapuriya NP, Mangtani KM, Ladva KD. An improved assay method for the estimation of ticagrelor hydrochloride by reverse phase liquid chromatography. International Journal of Pharmaceutical Sciences and Research. 2016; 7: 2009–2014.
26. Kale P, Agrawal Y, Soni, Patel P. Simultaneous quantification of ticagrelor and its metabolite deshydroxyethoxy Ticagrelor in human plasma by ultra-performance liquid chromatography electrospray ionization-tandem mass spectrometry. World Journal of Pharmaceutical Sciences. 2014;1-9,
27. Omaima J, Shyamala, Sharma JVC. Development and validation of stability indicating UPLC method for the estimation of ticagrelor in bulk and its tablet dosage form. Journal of Drug Delivery and Therapeutics. 2019; 9(1-s):201-205.
28. Gandi P, Rao YS, Rao KVP, Kumar TH. RP-HPLC method for the determination of zaltoprofen in bulk and pharmaceutical dosage form. Der Pharmacia Lettre. 2015, 7 (7):6-10.
29. Gowthami G, Rao KVP, Kumar TH, Rao YS. RP-HPLC Determination of Lafutidine in Bulk Drug and Pharmaceutical Dosage Form. International Journal of Pharmacy. 2015.
30. Rao KVP, Tanuja M, Rao YS, Kumar TH. Development and Validation of RP-HPLC method for the estimation of Zileuton in bulk and its dosage form. International Journal of Drug Delivery and Research. 2015, 7(1).
31. Sindhu N, Rao YS, Kumar TH and Rao KVP. RP-HPLC Method For Estimation Of Nisoldipine In Bulk And Pharmaceutical Dosage Form. International Journal of Pharmacy. 2015: 5(2).
32. Rao MT, Ratna VJ, Rao YS, Kumar TH. Development and Validation of RP-HPLC Method for the Determination of Itraconazole in Bulk and Capsule Dosage Form. International Journal of Pharmaceutical Science Review and Research. 2015; 31(2): 221-225.
33. Lakshmi GT, Rao YS, Rao K, Prasada V, Kumar TH. RP-HPLC Method for Estimation of Atomoxetine Hydrochloride in Bulk and Pharmaceutical Dosage Form. Research Journal Of Pharmaceutical Biological and Chemical Sciences. 2015; 6(2): 1208-14.
34. Gupta A, Jadhav V, Jain A. Analytical Method Development and Validation of Ticagrelor from Bulk and Formulation. Asian Journal of Pharmaceutical Research. 2019; 9(3):141-146.
35. Rao YS, Gandi P, Rao KVP and Kumar TH. Development and validation of RP-HPLC method for the determination of Zaltoprofen in bulk and pharmaceutical tablet dosage form. Journal of Chemical and Pharmaceutical Research. 2015, 7(1):5-9.
36. Kumar TH, Sri DS, Rao KVP and Rao YS. Validated RP- HPLC Method For Determination of Rosuvastatin Calcium In Bulk And Pharmaceutical Formulation. IJPSR. 2015; 6(7): 1000-05.
37. Bhavana V, Kumar TH, Rao YS, Rao KVP. RP-HPLC method for estimation of Solifenacin Succinate in API and Tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2019;9(3):118-122.
38. Siridevi PM, Kumar TH, Rao YS, Rao KVP. RP-HPLC Method For Quantification Of Empagliflozin In Pharmaceutical Formulation. Asian Journal of Pharmacy and Technology. 2019; 9(3): 208-211.
39. Sindhu SN, Rao YS, Kumar TH, Rao KVP. Method development and validation of RP-HPLC method for estimation of imatinib mesylate in pure and pharmaceutical dosage form. Der Pharmacia Lettre. 2015; 7 (3):33-38.
40. Sankar DG, Kumar HT, Krishna VM. UV Spectrophotometric determination of Duloxetine Hydrochloride. Asian Journal of Chemistry. 2009; 21(6).
41. Kumar TH, Reddy KM, Rishika D, Kumar PR. Estimation of Orlistat by UV Spectrophotometric method, International Journal of Pharmaceutical Science and Research. 2011; 2(9): 2469-2471.
42. Madhuri PL, Kumar TH, Rao YS, Rao KVP. UV Spectrophotometric Method for Estimation of Sacubitril in Synthetic Mixture. Asian Journal of Research in Chemistry. 2019; 12(1): 07-10.
43. Chaitanya PSV, Kumar TH., Rao YS, Rao KVP. Estimation of vortioxeine in bulk and pharmaceutical formulations by UV spectrophotometry. European Journal of Pharmaceutical and Medical Research. 2019; 6(2): 389-392.
44. Yamini M, Kumar TH, Rao YS, Rao KVP. Determination of Zonisamide in Bulk and Pharmaceutical Formulation by UV Spectrophotometric Method. International Journal of Pharmaceutical Science Review and Research. 2019; 54(2): 79-8.
45. Mahivish R, Manjunath SY, Kumar TH. UV Spectrophotometric Method for Estimation of Zileuton in Pharmaceutical Formulation. GSC Biological and Pharmaceutical Sciences. 2020: 13(1): 212-219.
46. Dhalape VM, Santosh TK and Pinjari VR. RP-HPLC Method Validation for Quantitative Analysis of Pemetrexed Disodium Hemipentahydrate. Research Journal of Pharmacy and Technology. 2020; 13(8):3685-3689.
47. Sabarathinam S and Vijayakumar TM. RP-HPLC Method Development and Validation of Midazolam: A CYP3A4 Probe Drug. Research Journal of Pharmacy and Technology. 2020; 13(8): 3565-3568.
48. Vitthal MD, Santosh T and Rahul VP. RP-HPLC Method Validation for Quantitative Analysis of Pemetrexed Disodium Hemipentahydrate. Research Journal of Pharmacy and Technology. 2020; 13(8):3685-3689.
49. Deep Shikha Sharma, Sheetu Wadhwa, Sachin Kumar Singh, Arya Ramanunny, Rajan Kumar. Estimation of 5-fluorouracil by high-performance liquid Chromatography Reversed-phase Validated method. Research Journal of Pharmacy and Technology. 2020; 13(9):4249-4254.
50. Gupta S. K., Sachan N., Chandra P., Sharma A. K. A Robustustic Eco-Friendly Analytical Method to Quantify Topotecan in Pharmaceuticals by RP-HPLC. Research Journal of Pharmacy and Technology. 2020; 13(9):4387-4390.
51. Sarvesh Sabarathinam, T M Vijayakumar. RP-HPLC Method Development and Validation of Midazolam: A CYP3A4 Probe Drug. Research Journal of Pharmacy and Technology. 2020; 13(8):3565-3568.
52. Khairi M. S. Fahelelbom, Moawia M. M. Al-Tabakha, Nermin A. M. Eissa, Dana Emad Eddin Obaid, Sadik Sayed. Development and Validation of an RP-HPLC Analytical Method for Determination of Lisinopril in Full and Split Tablets. Research Journal of Pharmacy and Technology. 2020; 13(6):2647-2652.
53. Kallol Jana, Beduin Mahanti. Development and Validation of a new improved RP-HPLC Method for estimation of Rosuvastatin calcium in pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2020; 13(6): 2886-2892.
54. ICH Proceedings of the International Conference on Harmonisation of Technical Requirement of Registration of Pharmaceuticals for Human Use (ICH Harmonised Tripartite Guidelines). Validation of Analytical Procedures: Methodology, Q2B.