Method development and validation for simultaneous estimation of methotrexate and curcumin in Bulk Drug by using RP-HPLC
Curcumin is the natural herb that shows effect in the treatment of cancer and rheumatoid arthritis and methotrexate is well known anticancer and anti-rheumatoid drug. Literature survey reveals that there was no method available for the selected drug combination. So, here an attempt has been made to develop simple, rapid and economic method for simultaneous estimation of methotrexate and curcumin in bulk drug by using RP-HPLC method. The percentage assay from optimized method was found to be 99.68% and 99.76% for methotrexate and curcumin respectively. The proposed method was validated for linearity, accuracy, precision and robustness according to ICH guidelines and were found to be within the standard range.
Keywords: RP- HPLC, methotrexate, Linearity, anticancer
2. Coates A, Abraham S, Kaye SB, Sowerbutts T, Frewin C, Fox RM, Tattersall MH, On the receiving end—patient perception of the side-effects of cancer chemotherapy.,European Journal of Cancer and Clinical Oncology, 1983; 19(2):203-208.
3. Khazir J, Riley DL, Pilcher LA, De-Maayer P, Mir BA, Anticancer agents from diverse natural sources, Natural product communications, 2014;9(11):195-167.
4. Takeda M, Khamdang S, Narikawa S, Kimura H, Hosoyamada M, Cha SH, Sekine T, Endou H, Characterization of methotrexate transport and its drug interactions with human organic anion transporters, Journal of Pharmacology and Experimental Therapeutics, 2002; 302(2):666-669.
5. Allegri P, Mastromarino A, Neri P, Management of chronic anterior uveitis relapses: efficacy of oral phospholipidic curcumin treatment. Long-term follow-up, Clinical Ophthalmology,2010; 4:1201-1207
6. Vallianou NG, Evangelopoulos A, Schizas N, Kazazis C, Potential anticancer properties and mechanisms of action of curcumin,Anticancer research,2015;35(2):645-51.
7. Jayaprakasha GK, Jagan Mohan Rao L, Sakariah KK,Improved HPLC method for the determination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin, Journal of agricultural and food chemistry, 2002; 50(13):3668-3672.
8. Moghbel, A., Zand-Moghaddamb, A., Rezaee, S., Pedram, M, High-Performance Liquid Chromatography Determination of Methotrexate in Plasma, Iranian Journal of Pharmaceutical Research, 2010; 2( 3): 149-152
9. El-Hady DA, El-Maali NA, Gotti R, Bertucci C, Mancini F, Andrisano V,Methotrexate determination in pharmaceuticals by enantioselective HPLC, Journal of pharmaceutical and biomedical analysis, 2005;37(5):919-925.
10. Li J, Jiang Y, Wen J, Fan G, Wu Y, Zhang C, A rapid and simple HPLC method for the determination of curcumin in rat plasma: assay development, validation and application to a pharmacokinetic study of curcumin liposome, Biomedical chromatography, 2009 ;23(11):1201-1207.
11. Ramshankar YV, Suresh S, A sensitive reversed phase HPLC method for the determination of curcumin, Pharmacognosy Magazine, 2009;5(17):71-76
12. Wichitnithad W, Jongaroonngamsang N, Pummangura S, Rojsitthisak P, A simple isocratic HPLC method for the simultaneous determination of curcuminoids in commercial turmeric extracts, Phytochemical Analysis, 2009; 20(4):314-319.
13. Banji D, Pinnapureddy J, Banji OJ, Saidulu A, Hayath MS, Synergistic activity of curcumin with methotrexate in ameliorating Freund's Complete Adjuvant induced arthritis with reduced hepatotoxicity in experimental animals, European journal of pharmacology, 2011;668(2):293-298.
14. Mishra A, Dewangan G, Singh WR, Hazra S, Mandal TK, A simple reversed phase high-performance liquid chromatography (RP-HPLC) method for determination of curcumin in aqueous humor of rabbit, Journal of advanced pharmaceutical technology & research, 2014; 5(3):147-149.
15. Suguna P, Sathyanarayana B, Chandrasekhar G, Narasimhulu B, Validation of HPLC method for the analysis of methotrexate in bulk drug and pharmaceutical dosage forms,J Chem Pharm Res, 2015; 7:27-33.
16. Sharma K, Giri K, Dhiman V, Dixit A, Zainuddin M, Mullangi R, A validated LC/MS/MS assay for simultaneous quantification of methotrexate and tofacitinib in rat plasma: application to a pharmacokinetic study, Biomedical Chromatography, 2015;29(5):722-732.
17. Joseph SK. Simultaneous Determination of Methotrexate and Sulfasalazine in Plasma by HPLC–DAD. 2015.
18. Roy M, Mohite M, Shah S, Development and validation of RP-HPLC method for thedetermination of methotrexate in bulk and pharmaceutical tablet dosages form, European Journal of Pharmaceutical and Medical Research, 2016; 3(5): 355-358
19. Jahromi LP, Mohammadi-Samani S, Ashrafi H, Azadi A,A reversed-phase high performance liquid chromatography (HPLC) method for bio-analysis of methotrexate ,TIPS. 2016;2(2):101-108.
20. Radha A, Ragavendran P, Thomas A, Kumar DS, A cost effective HPLC method for the analysis of curcuminiods, Hygeia.J.D.Med, 2016;8 (1) :115-120
21. Panigrahi S, Hirlekar R, A new stability indicating RP-HPLC method for determination of curcumin: an application to nanoparticulate formulation, Int J Pharm Pharm Sci., 2016;12:102-107.
22. Amanolahi F, Mohammadi A, Oskuee RK, Nassirli H, Malaekeh-Nikouei B, A simple, sensitive and rapid isocratic reversed-phase high-performance liquid chromatography method for determination and stability study of curcumin in pharmaceutical samples. Avicenna journal of phytomedicine. 2017;7(5):444.-447
23. Hirlekar R, Bhairy S, Kmismatrao A, Development and validation of RP-HPLC method for simultaneous estimation of curcumin and piperine, Int J App Pharma, 2018;10(5):43-44
24. Curcio M, Mauro L, Naimo GD, Amantea D, Cirillo G, Tavano L, Casaburi I, Nicoletta FP, Alvarez-Lorenzo C, Iemma F, Facile synthesis of pH-responsive polymersomes based on lipidized PEG for intracellular co-delivery of curcumin and methotrexate. Colloids and Surfaces B, Biointerfaces. 2018; 167:568-576.
25. ICH Harmonised Tripatite Guidelines. Validation of analytical procedure: text and methodology Q2 (R1), current step 4 version, parent guidelines on methodology, November 2005.
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 3.0 Unported License. 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 (SeeÂ The Effect of Open Access).