T. Vijayalaxmi, Vunjali Laxman Sai, Ramya Sri. S
T. Vijayalaxmi1*, Vunjali Laxman Sai1, Ramya Sri. S2
1Department of Pharmaceutical Analysis, Samskruti College of Pharmacy, Affiliated to JNTUH University, Hyderabad 501301, Telangana, India.
2Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telangana, 500007, India.
Volume - 15,
Issue - 1,
Year - 2023
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Cytarabine and Daunorubicin, in its pure form as well as in pharmaceutical dosage form. Chromatography was carried out on an Altima C18 (4.6mm x 150mm, 5µm) column using a mixture of ACN, Methanol and Phosphate buffer pH-4.6 (10:25:65 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 265nm. The retention time of the Cytarabine and Daunorubicin was 2.088, 6.068±0.02 min respectively. The method produces linear responses in the concentration range of 10-50mg/ml of Cytarabine and 20-100mg/ml of Daunorubicin. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Cite this article:
T. Vijayalaxmi, Vunjali Laxman Sai, Ramya Sri. S. HPLC Analytical Method Development and Validation for Estimation of Cytarabine and Daunorubicin in API and Pharmaceutical Formulation. Research Journal of Pharmaceutical Dosage Forms and Technology.2023; 15(1):7-3. doi: 10.52711/0975-4377.2023.00002
T. Vijayalaxmi, Vunjali Laxman Sai, Ramya Sri. S. HPLC Analytical Method Development and Validation for Estimation of Cytarabine and Daunorubicin in API and Pharmaceutical Formulation. Research Journal of Pharmaceutical Dosage Forms and Technology.2023; 15(1):7-3. doi: 10.52711/0975-4377.2023.00002 Available on: https://rjpdft.com/AbstractView.aspx?PID=2023-15-1-2
1. A New Analytical Method Validation and Quantification of Entacapone and its Related Substance in bulk G. Kumar, T.B. Patrudu, Tentu Nageswara Rao, M.V. Basaveswara Rao. Drug Product by HPLC. Asian J. Pharm. Ana. 2017; 7(1): 1-5. doi: 10.5958/2231-5675.2017.00001.1
2. Hamid Khan, Javed Ali. UHPLC: Applications in Pharmaceutical Analysis. Asian J. Pharm. Ana. 2017; 7(2): 124-131. doi: 10.5958/2231-5675.2017.00020.5
3. Ahmed Kareem Hussein Mubarak. Design and Synthesis of Cytarabine new Derivatives as a Possible an Imine Prod rugs with Potential to improve Therapeutic Criteria. Research J. Pharm. and Tech. 2018; 11(3): 1131-1136. doi: 10.5958/0974-360X.2018.00211.1
4. Nachiket S Dighe, Shashikant R Pattan, Deepak S Musmade, Abhijeet N Merekar, Manisha S Kedar, Deepak K Thakur, Pratik V Patel. Recent Synthesis of Marine Natural Products with Anticancer Activity: An Overview. Research J. Science and Tech. 2009; 1(2): 63-70.
6. Pragya Pathak, Rajender Mahal, Adarsh Kohli, Vinod Nimbran. A Quasi Experimental Study to Evaluate the Effectiveness of Progressive Muscle Relaxation on Anxiety and Depression among Hospitalised Cancer Patients receiving Radiotherapy. Asian J. Nur. Edu. & Research 3(1): Jan.-March 2013; Page 42-46.
7. Athar Javeth, R. G. Mathur, Molly Babu. A correlational survey to assess the level of stress, coping strategies, and quality of life of female cancer patients related to chemotherapy induced alopecia in Amala Cancer Hospital, Thrissur, Kerala. Asian J. Nur. Edu. and Research.2017; 7(1): 1-6. doi: 10.5958/2349-2996.2017.00001.5.
8. Sheeba Chellappan, Rajamanickam Rajkumar, Merlin Jeyapal. Cancer Pain Management: Teaching Program for Terminally ill Cancer Patients. Asian J. Nur. Edu. and Research.2017; 7(2): 151-154. doi: 10.5958/2349-2996.2017.00030.1
9. Bhagya Seela S, ShanmugaRaju P. Effectiveness of Structured Teaching Programme on Knowledge Regarding Preventive Measures of Oral Cancer among Late Adolescents in Selected Junior College, Karminagar, Telangana. Asian J. Nur. Edu. and Research.2017; 7(1): 21-25. doi: 10.5958/2349-2996.2017.00006.4
11. K. T. N. Jyothi, P. S. R. Subrahmanyam, A. Ch. Sravanthi. Application of Differential Equations in Medical Science. Research J. Science and Tech. 2017; 9(3):425-426. doi: 10.5958/2349-2988.2017.00074.2
12. Hemant Devidas Une, Lalita Bansidas Bhagure. The Anti-leukemic Potential of Cyclea peltata as Validated by Phytochemical and Cell Line Studies. Research Journal of Pharmacy and Technology. 2022; 15(3):1064-0. doi: 10.52711/0974-360X.2022.00178
13. Ana Murtasyidah, Betty Agustina Tambunan, Mia Ratwita Andarsini. Platelet Refractoriness Evaluation after Platelet Concentrate Transfusion in Pediatric Leukemia. Research Journal of Pharmacy and Technology. 2021; 14(8):4277-0. doi: 10.52711/0974-360X.2021.00743
14. Ankit Darji, Praful Bharadia. Studies on the Quantification of Mutation Resistance to Specific Drug Therapy in Chronic Myeloid Leukemia patients. Research Journal of Pharmacy and Technology. 2021; 14(8):4092-0. doi: 10.52711/0974-360X.2021.00709
15. ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization, IFPMA, Geneva; 2005.
16. ICH Q2A. Text on Validation of Analytical Procedures, International Conference on Harmonization. Geneva; 1994.
17. ICH Q2A. Text on Validation of Analytical Procedures, International Conference on Harmonization. Geneva; 1995.
18. Sura, R. S., CVS, S., & rachamalla, S. S. (2022). Bioanalytical RP-HPLC Method Development And Validation Of Clopidogrel Bisulfate In Wistar Rat Plasma And Its Application To Pharmacokinetic Study. International Journal of Applied Pharmaceutics, 14(1), 106–111. https://doi.org/10.22159/ijap.2022v14i1.43328