APPLICATION OF VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ARMODAFINIL IN BULK AND FORMULATION
Objective: The objective of the present study is to develop and validate a simple, rapid, sensitive reverse phase HPLC method for the determination of Armodafinil present in bulk and its pharmaceutical formulations.
Methods: The chromatographic separation was achieved by using Hypersil ODS C-18 (150 x 4.6 mm, 5Âµ) in an isocratic mode with mobile phase methanol: phosphate buffer 3.0 (60:40 %v/v) was used. The flow rate was 1 ml/min and effluent was monitored at 225 nm. The method was validated for validation parameters i.e. linearity, accuracy, precision and robustness according to ICH guidelines.
Results: The retention time of Armodafinil was 4.2 min and the linearity range of the method was 500-20000ng/ml with regression (r2) coefficient 0.9998. The method was validated for precision, accuracy, robustness and which were found to be within the acceptable limits according to the ICH guidelines. Also, the method was successfully applied for the estimation of Armodafinil in the marketed formulation of Nuvigil and the recovery was found to be>98%.
Conclusion: The developed method possess good selectivity, specificity, there is no interference found in the blank at a retention time of ARM and good correlation between the peak area and concentration of the drugs under prescribed conditions. Hence, the method can be applied for routine analysis of Armodafinil.
2. Russo M. Pharmacotherapy of excessive sleepiness: focus on armodafinil. Clin Med Ther 2009;1:415-32.
3. Mona D, Mary K, Edward TH, Ronghua Y, Philmore R. Pharmacokinetic profile of armodafinil in healthy subjects. Pooled analysis of data from tree randomized studies. Clin Drug Invest 2009;29:87-100.
4. Schwertner HA, Kong SB. Determination of modafinil in plasma and urine by reversed phase high-performance liquid chromatography. J Pharm Biomed Anal 2005;9:475-9.
5. Gorman SH. Determination of modafinil, modafinil acid and modafinil sulfone in human plasma utilizing liquid-liquid extraction and high-performance liquid chromatography. J Chromatogr B: Anal Technol Biomed Life Sci 2002;767:269-76.
6. Musuku A, Sojo LE, Chee P, Lum G, Axelson JE. Development and validation of a liquid chromatography mass spectrometry assay method for the determination of modafinil in human plasma. AAPS J 2011;73:558â€“63.
7. Nageshwararao R, Shinde DD, Kumar Talluri MVN. Enantioselective HPLC resolution of synthetic intermediates of armodafinil and related substances. J Sep Sci 2008;31:981â€“9.
8. Mamta PD, Anandan P, Arindam M. Development of rapid and sensitive method for estimation of armodafinil in human plasma by LC/MS/MS. Int J Appl Biol Pharm Technol 2011;2:323-7.
9. Devi Ramesh, Singirikonda Ramakrishna, Mohammad Habibuddin. Development and validation of new LC-MS/MS method for the determination of armodafinil in human plasma. Curr Pharm Anal 2012;8:295-305.
10. ICH, Q2B. Harmonized tripartite guideline, validation of analytical procedure: methodology, IFPMA, in: Proceedings of the International Conference on Harmonization; 1996.
11. USP (The United States pharmacopoeia convention) 30-NF 25, Rockville MD. 2007. p. 1005, 1776.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.