BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TICAGRELOR BY RP-HPLC
Objective: The main purpose of this study was to develop a simple, precise, rapid and accurate RP-HPLC method for the quantitative determination of ticagrelor in human plasma.
Methods: The separation was accomplished by the isocratic method by utilizing phenomenex C18 column on a Shimadzu binary gradient liquid chromatography system furnished with LC-20AD solvent delivery system, SPD-20-A photo-diode array detector and 20 Âµl loop volume in a rheodyne injector. The analyte was extracted by protein precipitation in the involvement of diethyl ether as a protein precipitator. The mobile phase was developed for the estimation of the drug in human plasma consists of acetonitrile and methanol in the ratio of 60:40% v/v. Separation was done with a flow rate of 1 ml/min at a detection wavelength of 254 nm.
Results: Retention time was found to be 4.503 min with a run time 10 min. Linearity shows in a range of 20-100 Âµg/ml, with a correlation coefficient of 0.9992 respectively. Stability studies of ticagrelor in plasma were carried out by, short term stability, long term stability and bench top stability studies. Short term stability, long term stability and bench top stability of ticagrelor was carried out from 20 and 100 Âµg/ml concentration and %RSD was ascertained 0.12% and 0.08%, 0.18% and 0.15%, 1.19% and 1.30% respectively.
Conclusion: The outcomes were observed to be inside the knowledge of ICH guidelines. The prepared solution was injected in triplicate, and % RSD was measured. Acquired results demonstrate that proposed strategy can be effortlessly and advantageously applied for routine examination of ticagrelor in human plasma
2. Goel D. Ticagrelor. The first approved reversible oral antiplatelet agent. Int J Appl Basic Med Res 2013;3:19-21.
3. RaeAnne, Benjamin Chavez. Ticagrelor (Brilinta), An antiplatelet drug for acute coronary syndrome. P and T; 2012. p. 562-8.
4. Khaja Pasha, Asgar Ali, Shahana Bana, Syeda Humair. Reverse phaseâ€“HPLC method for the analysis of tinidazole in the pharmaceutical dosage form and bulk drug. Int J Pharm Pharm Sci 2010;2:47-52.
5. Guideline on Bioanalytical method validation: European Medicines Agencies; 2011.
6. Sonawane LV, Poul BN, Usnale SV. Bioanalytical method validation and its pharmaceutical application a review. Pharm Anal Acta 2014;5:1-7.
7. Megha G Gore, Pratap S Dabhade. RP-HPLC method development and validation of azelnidipine. Int J Pharm Sci Res 2016;5:111-4.
8. Pushpa Latha E, Sailaja B. Bioanalytical method development and validation by HPLC: a review. J Appl Pharm 2014;1:1-9.
9. Choudary S, Saahil Arora, Tanvil Sharma. Bioanalytical method development and validation of ibuprofen using RP-HPLC. J Pharm Tech Res 2012;2:312-21.
10. Rutvik Pandya H, Rajeshwari Rathod, Dilip G. Development and validation for simultaneous determination of linagliptin and metformin drugs in human plasma by the RP-HPLC method. Pharmacophore 2014;6:202-18.