ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CYTARABINE AND DAUNORUBICIN AND THEIR DEGRADATION STUDIES IN BULK AND FORMULATION BY UPLCAbstract
The current investigation was Developing and validating a novel, simple, responsive, and stable UPLC method for the measurement of active pharmaceutical ingredients of Cytarabine and Daunorubicin. The chromato-graphic strategy utilized a phenyl column of dimensions 100 x 2.1 mm, 1.7 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (70:30) with a flow rate of 0.5 ml/min and the run time is 3min and a detector wavelength of 240 nm utilizing the PDA detector was given in the instrumental settings. The Retention time (Rt) of the Cytarabine and Daunorubicin were found to be 0.164min and 1.742 min. The proposed method was validated according to an international conference on harmonization (ICH) guidelines. The accuracy results of Cytarabine and Daunorubicin were found to be 100.4% & 99.8%, and the linearity of Cytarabine and Daunorubicin were 0.992 & 0.990. Precison results of Cytarabine and Daunorubicin were 0.69 and 0.52 and the LOD and LOQ values of Cytarabine 1.65µg/ml, and 5µg/ml and Daunorubicin are 0.726µg/ml and 2.2 µg/ml. The proposed method to be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.
M. Vijaya Kumari * and Ch. Balasekhara Reddy
Department of Pharmaceutical Analysis, Vignan Institute of Pharmaceutical Sciences, Deshmukhi (Village), Bhongir Yadadri (Dt.), Hyderabad, India and Research Scholar Acharya Nagarjuna University, Guntur, Andhra Pradesh, India, India.
27 August 2022
20 October 2022
17 November 2022
01 May 2023