Development and validation of stability indicating UPLC method for the estimation of ticagrelor in bulk and its tablet dosage form
The objective of the method was to develop a simple, rapid, sensitive, precise, accurate and validated Ultra Performance Liquid Chromatographic (UPLC) method for the estimation of Ticagrelor in tablet dosage form. Chromatographic separation was achieved on an acquity UPLC BDS C8 (150 x 4.6 mm, 5m) column with a mobile phase composed of Buffer 0.1% OPA (2.2 pH) and Acetonitrile in the ratio of 60:40 at a flow rate of 1.0 ml/min and 1 μl injection volume. The effluents were detected at a wavelength of 240 nm using TUV detector. The retention time of Ticagrelor was found to be at 0.942 min. %RSD of the Ticagrelor was found to be 0.7 The method was validated with respect to specificity, accuracy, linearity, precision, robustness. The correlation coefficient for Ticagrelor was found to be 0.999. Recovery of Ticagrelor in formulation was found to be 99.51% . LOD, LOQ values obtained from regression equations of Ticagrelor were 0.45, 1.35 respectively. Due to simplicity, high precision and rapidness the method can be successfully applied for estimation of Ticagrelor in tablet dosage form.
Keywords: Ultra Performance Liquid Chromatographic, Ticagrelor, Tablet dosage form.
2. 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):733-737.
3. 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, Innovare Academics Sciences Pvt. Ltd, 2017; 9(3):51-54
4. Tabassum K, Sarvesh R, Analytical Method Development and VALIDATION Studies OF Ticagrelor Tablets by RP-HPLC, International Journal of Applied Pharmaceutics, 2017; 9(4).
5. Ambasana MA, Kapuriya N, Faldu NJ, Ladva K, Development and validation of a UV spectrophotometric method for the determination of ticagrelor in bulk form, Der Pharmacia Lettre, 2014; 6(4):237-240.
6. Anil Kumar N, Naga Swathi PR, Sharmila D, Sharmila SK, Pawar AKM, A validated stability indicating method of UV-Spectrophotometry for the estimation of ticagrelor in bulk & marketed formulation, Der Pharmacia Lettre, 2016, 8(19):309-315.
7. Saravanan V., Revathi R., & Meera N. Method development and validation for the simultaneous estimation of lycopene and ubidecarenone by RP-HPLC in combined pharmaceutical dosage form. Journal of Drug Delivery and Therapeutics, 2016; 6(5):46-51. https://doi.org/10.22270/jddt.v6i5.1295
8. 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.
9. Bishnoi RS, Kumar M, Shukla AK, Jain CP, Development and validation of novel HPLC method for the estimation of Rutin in crude hydromethanolic leaf extract of Prosopis cineraria, Journal of Drug Delivery and Therapeutics. 2018; 8(6):68-73.
10. Kumar M, Shukla AK, Bishnoi RS, Jain CP, Development of UV Spectrophotometric Method for The Determination of Benidipine Hydrochloride by Using Quality By Design (QbD) Approach. International Journal of Applied Pharmaceutics, 2018; 10(4):92-97.
11. Kim D., Yousaf A., Li D., Kim J., Yong C., Cho K. and Choi H. Development of RP-HPLC method for simultaneous determination of docetaxel and curcumin in rat plasma: Validation and stability. Asian Journal of Pharmaceutical Sciences, 2017; 12(1):105-113.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).