A simple, specific and accurate reversed-phase high performance liquid chromatographic method was developed for the simultaneous determination of Capecitabine and Oxaliplatin, using a Hypersil BDS C18, 150x4.6 mm, 5µ column and a mobile phase composed of 10mM dipotassium hydrogen phosphate+0.1% TEA pH 5.0: Acetonitrile (50:50%v/v). The flow rate was 1.0 ml/min, and the detection wavelength was 245 nm. The injection volume was 20 µL. The retention times of Capecitabine and Oxaliplatin found 4.29 min and 5.52 min, respectively. Linearity was established for Capecitabine and Oxaliplatin in the range of 60-210µg/ml and 20-70 µg/ml, respectively. The percentage recoveries of Capecitabine and Oxaliplatin found to be in the range of 99.1-101.5% and 97.9-99.7 %, respectively. The proposed method validated for precision, accuracy, linearity range, and robustness. This method can successfully be employed for simultaneous quantitative analysis of Capecitabine and Oxaliplatin in the capsule.
Cite this article:
Krishna Patel, Dipti Patel. Simultaneous method development and Validation by HPLC for Capecitabine and Oxaliplatin in mucoadhesive microspheres containing capsules. Research Journal of Pharmacy and Technology. 2021; 14(6):3365-0. doi: 10.52711/0974-360X.2021.00585
Krishna Patel, Dipti Patel. Simultaneous method development and Validation by HPLC for Capecitabine and Oxaliplatin in mucoadhesive microspheres containing capsules. Research Journal of Pharmacy and Technology. 2021; 14(6):3365-0. doi: 10.52711/0974-360X.2021.00585 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-75
1. Pan D, Cheng J, Xiaojian D, Dafang Z, LiDing, Xiaoyan C. Simultaneous determination of Capecitabine and its three nucleoside metabolites in human plasma by high performance liquid chromatography–tandem mass spectrometry. Journal of Chromatography B. 2015; 989: 71-79.
2. Fatima A, Tangadpally R, Kondepudi R, Makula A. Analytical method development and Validation of Capecitabine in bulk by RP-HPLC Method. International Journal of Pharmacy. 2012;3(3): 177-180.
3. Sreevatsav S and A.K. Harishbabu. RP-HPLC Method Development and Validation of Capecitabine Extended Release Tablet Dosage Form. International Journal of Pharmaceutical Sciences and Research. 2013; 51: 4477-4487.
4. Chaitanya G, Ramana GV, Pawar AKM. RP-HPLC method development and Validation of Capecitabine in bulk drug and formulation. International Journal of Pharmacy and Analytical Research. 2016; 5(1): 190-198.
5. Breno N, Paula M, Thaiene A, Tais G, Marcilio C, Guilherme M. Development and Validation of a Simple and Selective Analytical HPLC Method for the Quantification of Oxaliplatin. Journal of Chemistry. 2015; 2015: 1-6.
6. Edla S, Sundhar BS. RP-HPLC Method for the Quantification of Oxaliplatin in Formulations. International Journal of Science Inventions Today 2012; 1(1): 32-41.
7. Alcindor T and Beauger N. Oxaliplatin: a review in the era of molecularly targeted therapy. Drug Development in Contemporary Oncology. 2011;18(1): 18-25.
8. Susanne N, Sandrine F, JulieS, Serge, Jean-Luc V. Quality control of pharmaceutical formulations containing cisplsatin, carboplatin, and Oxaliplatin by micellar and microemulsion electrokinetic chromatography (MEKC, MEEKC) Journal of Pharmaceutical and Biomedical Analysis. 2011; 55 (2): 253-258.
9. Chauhan A, Mittu B and Chauhan P. Analytical method development and validation: a concise review. J. Anal. Bioanal. Tech. 2015;(6): 233.
10. Mohamed N. Simultaneous Determination of Amlodipine and Valsartan. Analytical Chemistry Insights. 2011; 6: 53–59.
11. Chatwal GR. and Sham AK. Instrumental Methods of Analysis. Himalaya Publishing House, New Delhi, 2002 (5) 2.624-2.625.
12. Hemant Kumar T. and Asha CH.New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Valsartan in Pharmaceutical Formulation. International Journal of Pharmaceutical Sciences and Research. 2019; 10(5): 2633-2643.
13. International Conference on Harmonization, ICH Q2 (R1): Validation of analytical procedures: text and methodology. 1994.
14. ICH Guidance on Analytical Method Validation, in: Proceedings of the International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, 2002.
15. International Conference on Harmonization, ICH, Q2(R1), Validation of analytical procedures: text and methodology, in Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, 2005.
16. Sharma S, Goyal S, Chauhan K. A Review on Analytical Method Development and Validation. International Journal of Applied Pharmaceutics. 2018; 10 (6): 8-15.
17. Hema, Reddy S.A Review on new Analytical method Development and Validation by RP-HPLC International Research Journal of Pharmaceutical and Biosciences. 2017;4(3): 41-50.