DEVELOPMENT AND VALIDATION OF A HPLC-UV METHOD FOR SIMULTANEOUS DETERMINATION OF MOXIFLOXACIN HYDROCHLORIDE AND KETOROLAC TROMETHAMINE IN OCULAR FORMULATIONAbstract
A simple, rapid, and sensitive high-performance liquid chromatographic method with UV detection has been developed and validated according to the ICH guidelines for the quantitation of Moxifloxacin Hydrochloride (MOX), Ketorolac Tromethamine (KET) in pharmaceutical dosage form. Chromatographic separation was carried out in a Zorbax eclipse plus, C18 column (250 mm × 4.6 mm; 5 µm particle size) with simple mobile phase composition of 10 mM Potassium dihydrogen phosphate buffer with Triethylamine (pH 3.14) and acetonitrile (40:60, v/v) at a flow rate of 0.5 mL min-1 where detector was set at 302 nm with a total run time of 8 mins. The method was linear over the concentration range of 40-100, µg mL-1 with a correlation coefficient of 0.9891 and 0.994. Limit of quantifications (LOQ) of 13.3, 26.3 and limit of detections (LOD) 4.4, 8.7 µg mL-1 for MOX, and KET respectively. Accuracy and precision values of both within-run and between-run obtained from six different sets of three quality control (QC) samples analyzed in separate occasions for both the analytes ranged from 98.13% to 99.75% and 0.95% to 2.15%, respectively. Extraction recovery of analytes in pharmaceutical formulation from 97.82% to 98.68%. The developed and validated method was successfully applied to quantitative determination of MOX and KET in pharmaceutical formulation.
Tapas Majumder, Sarbojit Kundu*, Subrata Kumar Ray and Prasanta Kumar Barat
Central Drugs Laboratory, (Govt. of India), 3, Kyd Street, Kolkata-700 016, India.
24 March, 2014
19 June, 2014
29 June, 2014
01 July, 2014