VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORMAbstract
This paper describes a new validated Reverse-Phase High-Performance Liquid Chromatography (HPLC) method for the simultaneous determination of two anti-cancer drugs, Daunorubicin and Cytarabine (Ara-C). A simultaneous determination method saves cost and time as both drugs can be injected into a single HPLC system without the need to change or re-equilibrate with a new mobile phase. The objective of the study is to develop a simultaneous determination method of two anti-cancer drugs, Daunorubicin and Cytarabine. The mobile phase consists of a mixture (55:45 v/v) of 0.1% OPA: acetonitrile at a flow rate of 0.8 ml/min, with a PDA detector at 240 nm. Separation was achieved on a kromosil C-18 column (5 µm; 250 mm × 4.6 mm) maintained at 30 °C temperature in a column oven. The method was linear between 7.25 µg/mL – 43.5 µg/mL for Daunorubicin and 16.2 µg/Ml – 97.5 µg/mL for Cytarabine. The limit of detection was 0.29 µg/mL for Daunorubicin, and 1.15 µg/mL for Cytarabine and the limit of quantification was 0.88 µg/mL for Daunorubicin and 3.47 µg/mL for Cytarabine. The developed RP-HPLC method achieved good precision and accuracy. The developed and validated method was suitable to be used for routine analysis of Daunorubicin and Cytarabine.
K. Sujana * and V. Satyanarayana
Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, Andhra Pradesh, India.
17 July 2018
13 October 2018
16 October 2018
01 April 2019