RP-HPLC METHOD FOR QUANTIFICATION OF OROTIC ACID IN CAPSULE FORMULATIONAbstract
A simple, sensitive and specific RP-HPLC method was developed and validated for the determination of Orotic acid in bulk and capsule dosage form. Chromatography was carried out on an Enable C18G (250 × 4.6 mm i.d.,5µ) column using filtered and degassed mixture of acetonitrile and methanol in the ratio of 60:40% v/v as mobile phase at a flow rate of 1 ml/min and effluent was monitored at 280 nm. The method was linear over the concentration range of 10 – 70 µg/ml with a correlation coefficient of 0.999. The retention time of the drug was 9.1 min. The proposed method was validated by determining sensitivity, accuracy, precision, robustness studies. The developed method was effectively applied to capsules of orotic acid, and the % assay of the drug was found to be 99.65%. The method is simple, accurate, precise and reproducible and hence can be applied for routine quality control analysis of orotic acid in pure and capsule dosage form.
T. H. Kumar *, D. Jhanavi, K. V. P. Rao and Y. S. Rao
Department of Pharmaceutical Analysis and Quality Assurance, Vignan Institute of Pharmaceutical Technology, Duvvada, Visakhapatnam, Andhra Pradesh, India.
31 August 2018
28 November 2018
06 December 2018
01 May 2019