A VALIDATED ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF CYTARABINE AND DAUNORUBICIN IN BULK AND INFUSION FORMULATION BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

  • PRASANTHI CHENGALVA Department of Pharmaceutical Analysis, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh, India.
  • LATHA LAVANYA PEDDAVENGARI Department of Pharmaceutical Analysis, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh, India.
  • MADHAVI KUCHANA Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), Tirupati, Andhra Pradesh, India.

Abstract

Objective: The novel liposomal infusion formulation of cytarabine and daunorubicin liposomal infusion is considered as new hope in acute myeloid leukemia treatment. The objective of the present study is to develop and validate a simple, rapid, accurate, precise and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of cytarabine and daunorubicin in bulk and infusion formulation.


Methods: The chromatographic separation of the drugs was achieved on Denali C18 (250 mm×4.6 mm, 5 μm) in isocratic mode with mobile phase consisting of water (pH was adjusted to 3):acetonitrile in the ratio of 55:45 with a flow rate of 1 ml/min at a detection wavelength of 240 nm using photodiode array (PDA) detector. The column temperature was set at 30°C with 10 μl injection volume. The proposed method was validated as per the International council for Harmonisation (ICH) guidelines.


Results: The retention times for cytarabine and daunorubicin were found to be 2.323±0.12 min and 3.140±0.16 min, respectively. Linearity (r2=0.999) was observed over a concentration range of 16.2–97.5 μg/ml for cytarabine and 7.2–43.5 μg/ml for daunorubicin. The percentage relative standard deviation (RSD) for precision studies was found to be 0.2 for both the drugs.


Conclusion: A simple, rapid, economic, accurate, and precise RP-HPLC method was developed for simultaneous quantitative estimation of cytarabine and daunorubicin, and the method was validated as per the ICH guidelines. Hence, the method can be employed for the routine analysis of cytarabine and daunorubicin in bulk and infusion formulation.

Keywords: Cytarabine, Daunorubicin, Reverse-phase high-performance liquid chromatographic,, Method development, Method validation

References

1. Kirthi C, Azra A, Mounika R, Aamir AS, Aparna Y, Sanjeev S. A study on the adverse effects of anticancer drugs in an oncology center of a tertiary care hospital. Int J Pharm Pharm Sci 2014;6:580-3.
2. Shefali A, Shilpi A, Shailey S. Anticancer activities of thiosemicarbazides thiosemicarbazones: A review. Int J Pharm Pharm Sci 2014;6:34-41.
3. Suman P, Rao TS, Reddy KV. Development of stability-indicating RP–HPLC method for estimation of daunorubicin-a chemotherapic drug in bulk and pharmaceutical formulations. World J Pharm Res 2017;6:1158-74.
4. Lukawska M, Oszczapowicz L, Jelinska A, Piontek JC, Zajac M, Dobrowolski, L, et al. Development and validation of RP-HPLC method for determination of novel derivatives of daunorubicin. Chem Anal 2009;54:907-17.
5. Anna J, Marianna Z, Judyta C, Kinga G, Bartosz T, Anna K, et al. Validation of a stability indicating LC-UV Method for [(N-Morpholine)methylene] daunorubicin hydrochloride. Chromatographia 2008;67:107-11.
6. Zhang H, Xian-Rong Q, Zhang Q. HPLC determination of daunorubicin hydrochloride in its liposomes. Chin J Pharm Anal 2002;22:282-4.
7. Varanasi S, Rohini A, Pravallika K, Rani AP, Rahaman A. Development and validation of a novel UV-Visible spectrophometric method for cytarabine in bulk and pharmaceutical dosage forms. Pharm Lett 2013;5:51-5.
8. Varanasi S, Rohini A, Pravallika K, Rani AP, Rahaman A. Development of RP-HPLC method for estimation of cytarabine in bulk and pharmaceutical dosage forms. Int J Pharm Sci Res 2013;4:4573-6.
9. Anuj B, Satyavert L, Manu C. Development of a stability indicating RP-HPLC method for determination of anticancer agent cytarabine in lyophilized dosage form. Eurasian J Anal Chem 2012;7:160-7.
10. Marchenko S, Trukhacheva T, Gubina L, Moiseev D, Petrov P, Zhebentyaev A. HPLC-based quality control of cytarabine preparations. Pharm Chem J 2006;40:678-82.
11. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures; Text and Methodology ICH Q2 (R1); 2005.
Statistics
168 Views | 52 Downloads
How to Cite
PRASANTHI CHENGALVA, LATHA LAVANYA PEDDAVENGARI, and MADHAVI KUCHANA. “A VALIDATED ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF CYTARABINE AND DAUNORUBICIN IN BULK AND INFUSION FORMULATION BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 8, June 2019, pp. 128-31, https://innovareacademics.in/journals/index.php/ajpcr/article/view/34293.
Section
Original Article(s)