RP-HPLC Method Development and Validation of Moxifloxacin Hydrochloride & Ketorolac Tromethamine in Bulk and its Pharmaceutical Formulation

A. A. Phalphale, D. P. Ambhore, K. R. Biyani

Abstract: A simple, rapid, precise, and accurate, reversed phase high performance liquid chromatographic method was developed and validated for simultaneous determination of Moxifloxacin Hydrochloride (MOX) & Ketorolac Tromethamine (KET). The chromatographic separation was achieved on Grace 4.6 (id) x 250 mm column at detector wavelength of 319 nm, using an mobile phase consisting of methanol and buffer in a ratio of 50:50 pH 4.4 at a flow rate 1ml/min. The retention time for Moxifloxacin Hydrochloride (MOX) & Ketorolac Tromethamine (KET). were found to be 5.218 and 7.149 respectively. The method showed adequate precision with a relative standard deviation (RSD) smaller than 3%. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentration used. The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of Moxifloxacin Hydrochloride & Ketorolac Tromethamine in ophthalmic solution. The analytical procedure is reliable and offers not only advantages in terms of speed but also low cost of reagents.

Keywords: Moxifloxacin Hydrochloride & Ketorolac Tromethamine, HPLC