A validated stability-indicating high performance liquid chromatographic method for moxifloxacin hydrochloride and ketorolac tromethamine eye drops and its application in pH dependent degradation kinetics

Abstract

Background and Aim:A fixed dose combination of moxifloxacin hydrochloride and ketorolac tromethamine is used in ratio of 1:1 as eye drops for the treatment of the reduction of post operative inflammatory conditions of the eye. A simple, precise, and accurate High Performance Liquid Chromatographic (HPLC) method was developed and validated for determination of moxifloxacin hydrochloride and ketorolac tromethamine in eye drops. Materials and Methods: Isocratic HPLC separation was achieved on a ACE C 18 column (C 18 (5 μm, 150 mm × 4.6 mm, i.d.)) using the mobile phase 10 mM potassium di-hydrogen phosphate buffer pH 4.6-Acetonitrile (75:25 v/v) at a flow rate of 1.0 mL/min. The detection was performed at 307 nm. Drugs were subjected to acid, alkali and neutral hydrolysis, oxidation and photo degradation. Moreover, the proposed HPLC method was utilized to investigate the pH dependent degradation kinetics of moxifloxacin hydrochloride and ketorolac tromethamine in buffer solutions at different pH values like 2.0, 6.8 and 9.0. Results and Conclusion: The retention time (t R ) of moxifloxacin hydrochloride and ketorolac tromethamine were 3.81±0.01 and 8.82±0.02 min, respectively. The method was linear in the concentration range of 2-20 μg/mL each for moxifloxacin hydrochloride and ketorolac tromethamine with a correlation coefficient of 0.9996 and 0.9999, respectively. The method was validated for linearity, precision, accuracy, robustness, specificity, limit of detection and limit of quantitation. The drugs could be effectively separated from different degradation products and hence the method can be used for stability analysis. Different kinetics parameters like apparent first-order rate constant, half-life and t 90 (time for 90% potency left) were calculated.

Spectrophotometric determination and spectroscopic studies on Schiff base and charge transfer complex of ketorolac tromethamine

“…A survey of literature revealed that the KT has been analyzed in pharmaceutical preparations either alone or in combination with other drugs by HPLC (Kumaraswamy et al 2012;Razzaq et al 2012;Tsvetkova et al 2012;Dave et al 2013;Dubey et al 2012), HPTLC (Devarajan et al 2000;Vandana et al 2013), voltammetry (Squella et al 1997), and micellar electrokinetic chromatography (Orlandini et al 2004). Though these analytical procedures are sensitive, it entails a disadvantage of not being simple and requiring sophisticated experimental setup, increased cost of analysis and high consumption of solvents by the mobile phase for the chromatographic techniques.…”

Degradation Study of Ketorolactromethamine by a Validated UPLC Method

“…Forced degradation studies of the bulk drug sample were also performed using the following conditions: acid hydrolysis (0.1N HCl, 1N HCl), basic hydrolysis (0.1 N NaOH, 1N NaOH), heat (60-80°C for 1 hr), photolytic (UV and sunlight for up to 3 hr), oxidation (3% hydrogen peroxide for 1 hr). [21][22][23][24] Still the degradation study is needed to get a clear scenario of its degradation ways.…”

Estimation of Ketorolactromithamine in Phamaceutical Samples and Biofluids by The New Validated UPLC Method

“…Fluid retention and edema have been reported with the use of ketorolac and it should therefore be used with caution in patients with cardiac decompensation, hypertension or similar conditions. Ketorolac is not recommended for pre- operative analgesia or co-administration with anesthesia because it inhibits platelet aggregation and thus may be associated with an increased risk of bleeding [5,6]. Ketorolac is not recommended for long-term chronic pain patients.…”