Development and Validation of a Stability-Indicating LC-UV Method for Simultaneous Determination of Ketotifen and Cetirizine in Pharmaceutical Dosage Forms

Purpose: To develop and validate stability-indicating reversed phase high performance liquid chromatographic method for simultaneous determination of ketotifen fumarate and cetirizine dihydrochloride in solid dosage forms.Methods: Chromatographic separation was achieved on Grace Smart C18 column (250 × 4.6 mm, 5 μm) using an isocratic mobile phase that consisted of acetonitrile and 10 mM disodium hydrogen phosphate buffer (pH 6.5) in a ratio of 45:55 % v/v at a flow rate of 1 mL/min. Detection was carried out at 230 nm. Salbutamol sulphate was used as an internal standard. The drugs were exposed to hydrolytic (acid and alkaline), oxidative, reductive and neutral stress conditions, and the stressed samples analyzed by the proposed method. Validation of the method was carried out as per International Conference of Harmonization (ICH) guidelines.Results: The retention time for ketotifen, salbutamol and cetirizine was 2.05, 5.37 and 6.77 min, respectively. In stress studies, it was observed as cetirizine was more labile in acidic, oxidative and neutral conditions than ketotifen. Both the drugs were found comparatively stable in alkaline, neutral condition and labile in reductive condition. The method was linear in the concentration range of 1 - 30 μg/mL and 10 - 300 μg/mL for ketotifen and cetirizine, respectively.Conclusion: The developed method is specific and stability-indicating as no interfering peaks of degradants and excipients were observed. Thus, the method is suitable for application in the simultaneous quality control of both drugs.Keywords: Ketotifen, Cetirizine, Stability indicating method, Stressed conditions, Validatio

FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF ZOLMITRIPTAN

Introduction: Zolmitriptan is used to treat migraine headache, and it works only when a migraine attack has started, it will not stop from getting an attack. Zolmitriptan is rapidly and well absorbed, the absolute bioavailability is approximately 40percent.Objective: The present study is to formulate and evaluate an Orodispersible tablet for Zolmitriptan to treat migraine headache with rapid onset of action and also to improve the bioavailability by avoiding the first pass hepatic metabolism.Material and Methods: Orodispersible tablets containing the Zolmitriptan by using different diluents such as Avicel, Spray dried lactose, Pearlitol and Starlac and different super disintegrant such as SSG, L-HPC, CCS and Crospovidone. Tablets were prepared by direct compression method and sublimation method by using Menthol and Camphor as subliming agent and their pre and post compression parameters were determined. The dissolution studies were performed at 37°C±5°C and at 50 rpm in pH 6.8 phosphate buffer.Results: The drug content of all the formulations was within the acceptable limits. The tablets containing Avicel as diluents with L-HPC as super disintegrate showed less disintegration time with maximum drug release. So we used Avicel for sublimation method by using Menthol and Camphor as subliming agent and found Menthol as the better subliming agent.Conclusion: Formulation with insoluble diluents and disintegrants were found to be better than tablets containing soluble diluents and disintegrants. By sublimation method, menthol was found better than camphor in disintegration and drug release.Key words: Orodispersible tablets, diluents, disintegrants, Zolmitriptan