SIMULTANEOUS ESTIMATION OF HYDROCORTISONE AND KETOCONAZOLE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHODAbstract
A simple, selective, rapid, precise and economical reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of hydrocortisone and ketoconazole from pharmaceutical formulation. The method was carried out on a C18 (25 cm × 4.6 mm i.d., 5 μ) column with a mobile phase consisting of methanol: water (adjusted to pH 3.0 using triethylamine) in the ratio of 70:30 v/v. The retention time of hydricortusone and ketoconazole was 3.50 min and 6.00 min respectively with the flow rate of 1mL/ min. Eluents were detected at 221 nm. The linear regression analysis data for the linearity plot showed good linear relationship with correlation coefficient value for hydrocortisone and ketoconazole were R2 = 0.9995 and R2 = 0.9996 in the concentration range of 10 – 40µg. mL-1, 20 – 80 µg. mL-1 respectively. The relative standard deviation for intra-day precision was lower than 2.0 %. The method was validated according to the ICH guidelines. The method was also found to be robust. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability.
R. M. Naik *, S. Gumpula and P. S. Mhaskar
Department of Pharmaceutical Analysis and Quality Assurance, Gland Institute of Pharmaceutical Science, Shivampet Mandal, Medak, Telangana, India.
23 February, 2018
04 May, 2018
13 May, 2018
01 November, 2018