A STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DAUNORUBICIN AND CYTARABINE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:Daunorubicin, Cytarabine, RP-HPLC, validation, stability studies
Objective: A simple, accurate, and precise method was developed for the simultaneous estimation of daunorubicin and cytarabine dosage form using reverse-phase HPLC and validated with different parameters such as accuracy, precision, repeatability, linearity, limit of detection (LOD), and limit of quantitation (LOQ) as per ICH Q2R1 guidelines.
Methods: The chromatogram was run through Agilent C18 Column of dimensions 150×4.6 mm, 5 m. Mobile phase containing 0.01N KH2PO4: Methanol taken in the ratio 50:50 was pumped through the column at a flow rate of 1.0 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 240 nm.
Results: Retention times for daunorubicin and cytarabine were found to be 2.433 min and 3.045 min. The %RSD of the daunorubicin and cytarabine was found to be 0.7 and 0.4, respectively. The %Recovery was obtained as 99.96% and 100.40% for daunorubicin and cytarabine, respectively. LOD and LOQ values obtained from regression equations of daunorubicin and cytarabine were 0.08 μg/ml, 0.24 μg/ml and 0.94 μg/ml, 2.86 μg/ml, respectively. The regression equation for daunorubicin is y=28587x+3141 and y=35995x+37534 for cytarabine.
Conclusion: The method developed was simple and economical that can be adopted in regular quality control tests in industries.
Chemocare Place Unknown. Available from: https://www.chemocare. com/chemotherapy/drug-info/daunorubicin.aspx
Place Unknown. Available from: https://www.chemocare.com/ chemotherapy/drug-info/cytarabine.aspx
Shabir GA. HPLC method development and validation for pharmaceutical analysis. Pharm Technol Eur 2004;16:1-5.
Vidushi Y, Meenakshi B. A review in HPLC method development and validation. Res J Life Sci Bioinform Pharm Chem Sci 2017;2:166-78.
Varanasi SN, Murthy AR, Pravallika KE, Rani AP, Rahaman SA. Development and validation of RP-HPLC method for estimation of cytarabine in bulk and pharmaceutical dosage forms. IJPSR 2013;4:4573-76.
Available from: https://www.go.drugbank.com/drugs/DB00694
Available from: https://www.go.drugbank.com/drugs/DB00987
Validation of Analytical Procedures: Text and Methodology. Vol. Q2. 2005; Geneva, Switzerland: ICH Guidelines. p. R1.
Rawat T, Pandey IP. Forced degradation studies for drug substances and drug products-scientific and regulatory considerations. J Pharm Sci Res 2015;7:238-41.
Charde MS, Kumar J, Welankiwar AS, Chakole RD. Development of forced degradation studies of drugs. Int J Adv Pharm 2013;2:34-9.
Skoog AD, Holler FJ, Crouch RS. An Introduction to Chromatographic Separations. Instrumental Analysis. India: Cengage Learning: 2012. p. 836-9.
Khopkar SM. Principles of Analytical Chemistry. Basic Concepts of Analytical Chemistry. 3rd ed. New Delhi: New Age International Publishers; 2012. p. 111-25.
Skoog AD, Holler FJ, Crouch RS. Liquid Chromatography. Instrumental Analysis. India: Cengage Learning; 2012. p. 893-904.
Khopkar SM. High Performance Liquid Chromatography. Basic Concepts of Analytical Chemistry. 3rd ed. New Delhi: New Age International Publishers; 2012. p. 197-204.
Gupta V, Jain AD, Gill NS, Kapil. Development and validation of HPLC method. Int Res J Pharm Appl Sci 2012;2:1-5.
Hokanson GC. A life cycle approach to the validation of analytical methods during pharmaceutical product development. Part 1: The initial validation process. Pharm Technol 1994;21:92-100.
Green JM. A practical guide to analytical method validation. Anal Chem. 1996;68:305-9.
Aswathy SR, Muhas C, Sruthy AS, Devi Swapna PV, Gopinath U. Validation and application of RP-HPLC method for quantification of Enrofloxacin in pure and veterinary dosage forms. IJPPS 2021;14:42-47.
Pradhan N, Rajkhowa H, Giri H, Shrestha B. Simultaneous spectrophotometric estimation of moxifloxacin hydrochloride and doxorubicin hydrochloride. IJPPS 2015;7:21-6.
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