Development and validation of new analytical method for the simultaneous estimation of daunorubicin and cytarabine in bulk and pharmaceutical dosage form
A simple, Accurate, precise method was developed for the simultaneous estimation of the Daunorubicin and Cytarabine inhalation dosage form. Chromatogram was run through BDS C18 150 x 4.6 mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 240nm. Retention time of Daunorubicin and Cytarabine were found to be 2.245 min and 2.813. %RSD of the Daunorubicin and Cytarabine were and found to be 0.6and 0.3 respectively. %Recovery was obtained as 99.39% and 99.26% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equations of Daunorubicin and Cytarabine were 0.03, 0.10 and 0.31, 0.94 respectively. Regression equation of Daunorubicin is y = 2677x + 703.5, y = 2524x + 104.7 of Cytarabine.Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
4. Suman P, Sivarao T and Reddy VSK: Development and validation of a stability-indicating RP-HPLC method for estimation of Daunorubicin - a chemotherapic drug in bulk and pharmaceutical formulations. World Journal of Pharmaceutical Research 2017; 1158-1174.
5. Murthy V, Rohini A, Pravallika KE, Prameela R A and Rahaman SA: Development and validation of RP-HPLC method for estimation of Cytarabine in bulk and pharmaceutical dosage forms. International Journal of Pharmaceutical Sciences and Research 2013; 4573-4576.
6. Bhatnagar A, Loura S and Chaudhary M: A stability indicating RP-HPLC method for determination of anticancer agents Cytarabine in the lyophilized dosage form. Eurasian Journal of Analytical Chemistry 2012; 160-167.
7. Murthy V, Rohini A, Pravallika KE, Prameela RA and Rahaman SA: Development and validation of a novel UV-Visible spectrophotometric method for Cytarabine in bulk and pharmaceutical dosage forms. Scholars Research Library 2013; 51-55.
8. Kushagra R: Method development and validation of RP- HPLC method for simultaneous estimation of Daunorubicin and Cytarabine in the synthetic World Journal of Pharmacy and Pharmaceutical Sciences 2018; 1301-1310.
9. ICH harmonized tripartite guideline, validation of analytical procedures: text and methodology Q2 (R1); 27 October 1994; 1-13.
10. Rao CP, Rahaman SA, Prasad YR, Reddy PG. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. International Journal of Pharmaceutical Research and Development. 2010 Nov;2(9):69-76.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.