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ABSTRACT:
A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Olopatadine in pharmaceutical dosage form. Isocratic elution at a flow rate of 1.0 mL min -1 was employed on a Kromasil C18 column at ambient temperature. The mobile phase consisted of methanol: phosphate buffer 60:40 (v/v) and the detection wavelength was at 246 nm. Linearity was observed in concentration range of 10-60 µg/mL. The retention time for Olopatadine was 2.4 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Olopatadine in pharmaceutical dosage forms.
KEY WORDS: Dosage forms, Method development, Validation, Olopatadine, RP-HPLC
INTRODUCTION:
The drug Olopatadine (Fig1) generally available as Olopatadine Hydrochloride, is a dibenzoxipine derivative used for systemic treatment of allergic rhinitis, urticaria, and bronchial asthma. Chemically it is described as {(11Z)-11-[3-(dimethylamino) propylidene]-6,11 -dihydrodibenzo [b,e] oxepin-2-yl}acetic acid1. Olopatadine is an anti-histaminic, with selective H1 -receptor antagonist activity as well as anticholinergic and mast cell stabilizer. Its principal effects are mediated via inhibition of H1 receptors. These drugs selectively bind to H1 receptors there by blocking the actions of endogenous Histamine. They act on the bronchi, capillaries, and other smooth muscles. Olopatadine is commercially available as tablets, ophthalmic solution and nasal spray.
Literature survey reveals that few spectrophotometric method2-4 HPLC method5, HPTLC methods6, LC-MS method 7-8 has been reported for the estimation of Olopatadine. The aim of the present study is to develop a simple, precise and accurate reversed-phase HPLC method for the estimation of Olopatadine in pharmaceutical dosage form as per ICH guidelines9.
MATERIALS AND METHOD:
Instrumental and analytical conditions
The HPLC analysis was carried out on Waters HPLC system (2695 module) equipped with 2487 dual lambda detector with auto Sampler and running on Waters Empower software. The column used is Kromasil C18 (150 × 4.6 mm, packed with 5 µ m) and detection was performed at 246 nm. The injection volume of sample was 20 µ L and the run time was 5 minutes. An isocratic mobile phase containing methanol and 0.02 M phosphate buffer at 60: 40 (v/v) at the pH 3.5 was carried with the flow rate at 1.0mL min-1. The mobile phase was filtered through 0.4µ m...