Volume : 09, Issue : 06, June – 2022

Title:

33.A NOVEL METHOD DEVELOPMENT AND VALIDATION OF DECITABINE AND CEDAZURIDINE USING RP-HPLC METHOD

Authors :

Shaik Ejas*,Y. Rajendra, Khaja Zeeyauddin

Abstract :

The objective of the current work is to develop a simple, efficient, economical and compatible RP-HPLC method for the analysis of Decidabine and cidazuridine in bulk, dosage forms. Samples were separated on Phenomenex luna C18, 150 mm X 4.6 mm, 5m column with mobile phase composed of Methanol: Buffer (pH 3.75 with Potassium dihydrogen ortho Phosphate in isocratic mode. The detection wavelength was fixed at 225nm. The retention time of Decidabine and cidazuridine was 4.1 min and the method showed a good linearity in the concentration range of 25-150µg/mL with a correlation coefficient of 0.999. The method was validated for specificity, linearity, limit of detection, limit of quantification, precision, robustness and stability. All the validation parameters were within the compendia requirements. The proposed method was successfully adopted for the analysis in bulk, pharmaceutical dosage forms.
Keywords: Decidabine and cidazuridine , Phenomenex luna Column, PDA Detection, RP HPLC

Cite This Article:

Please cite this article in press Shaik Ejas et al, A Novel Method Development and Validation Of Decitabine And Cedazuridine Using RP-HPLC Method., Indo Am. J. P. Sci, 2022; 09(6).,

Number of Downloads : 10

References:

1. Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2011). Introduction to modern liquid chromatography. John Wiley&Sons.
1. Sahil, K., Akanksha, M., Premjeet, S. and Ganganagar, S., 2012. Validation of analytical procedures: a comparison of ICH vs pharmacopoeia vs FDA.
2. www.rxlist.com.
3. Tian, L., Huang, Y., Jia, Y., Hua, L. and Li, Y., 2008. Development and validation of a liquid chromatography–tandem mass spectrometric assay for pitavastatin and its lactone in human plasma and urine. Journal of Chromatography B, 865(1-2), pp.127-132.
4. Kumar, S.N. and Baghyalakshmi, J., 2007. Determination and quantification of pitavastatin calcium in tablet dosage formulation by HPTLC method. Analytical letters, 40(14), pp.2625-2632
5. Antony raj gomaset al 1 A.Gomas, P. Ram, N. Srinivas and J. Sriramulu, “Destruction Path for Decitabine as well as Cedazuridine Calcium by Validated Stability Indicating UPLC Technique,” American Journal of Analytical Chemistry, Vol. 1 No. 2, 2010, pp. 83-90. doi: 10.4236/ ajac.2010.12011.
6. Hiral J. Panchalet al 4 JPC – Journal of Planar Chromatography – Modern TLCVolume 21, Number 4/August 2008.
7. LvHet al 5 Clinicachimicaacta; global journal of scientific chemistry 386:1 -2 pg 25-30.
8. Kumar, N.S., Nisha, N., Nirmal, J., Sonali, N. and Bagyalakshmi, J., 2011. HPLC determination of pitavastatin calcium in pharmaceutical dosage forms. Pharm Anal Acta, 2(119), p.2.
9. El-Bagary, R.I., ElKady, E.F. and Kadry, A.M., 2012. Spectrofluorometric determination of certain antihyperlipidemic agents in bulk and pharmaceutical preparations. Spectroscopy: An International Journal, 27(2), pp.83-92
10. MarothHPLCamsi Krishna et alia 8 ISSN: 0973-4945; CODEN ECJHAO http://www.ejournals.net E-Journal of Chemistry Vol. 4, No. 2, pp 272-278, April 2007.
11. HiralPanchalet al 9 International Journal of Pharm Technology Research Study CODEN (United States): IJPRIF ISSN: 0974-4304 Vol.3, No. 4, pp 2155-2161, Oct-Dec 2011.
12. Jaiswal, Y., Talele, G. and Surana, S., 2005. Quantitative analysis of ethamsylate and mefenamic acid in tablets by use of planar chromatography. JPC-Journal of Planar Chromatography-Modern TLC, 18(106),
13. Riley, C.M. and Rosanske, T.W., 1996. Development and validation of analytical methods. Elsevier.
14. Brown, P.R., 2000. Advances in Chromatography: Volume 40. CRC Press.
15. Ahuja, S. and Scypinski, S. eds., 2001. Handbook of modern pharmaceutical analysis (Vol. 3). Academic press.