Dilip A. Patil

Abstract

This research describes the stability indicating RP-HPLC method in pharmaceutical tablet dosage forms for simultaneous estimation of Levocetirizine dihydrochloride (LEV) and Montelukast Sodium (MON). The proposed RP-HPLC method was developed using separation module Waters 2695 with PDA detector and chromatographic separation was performed at a flow rate of 1 mL / min using column Hypersil BDS C18 (250/4.6 mm, 5 ?m) with a run time of 10 min. The mobile phase consisted of a 40:60% v / v Phosphate buffer and acetonitrile, pH with orthophosphoric acid was adjusted to 7.0 and the eluents were scanned at 230 nm using a PDA detector. Retention times for LEV and MON were 3.06 min, and 6.76 min, respectively. A linearity response was observed with a concentration range of 12.56–37.68 ?g / mL for LEV and 23.78–71.20 ?g / mL for MON.  Limit of detection and limit of quantification for LEV are 0.079?µg/mL and 0.239?µg/mL and for MON are 0.156?µg/mL and 0.473?µg/mL, respectively. The stability indicating method was developed by subjecting the drugs to stress conditions such as acid, base hydrolysis, oxidation, neutral, photo- and thermal degradation, and the degraded products produced from the samples were successfully solved. Keywords: Levocetirizine dihydrochloride, Montelukast Sodium, RP-HPLC, stability indicating

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Abstract

The goal of this study is to carry out degradation studies of Levocetirizine market-available tablet brands. Forced degradation is the process which involves degradation of the drug products which can be studied to determine the molecule’s stability. Various brands of levocetirizine dihydrochloride (Okacet-L, LECOPE, Levocet, 1-AL) were used. It is an H1 receptor antagonist and is used in the treatment of persistent or seasonal allergic rhinitis and chronic idiopathic urticaria. As per ICH recommendations, this drug has been subject to various stress conditions during the study. In the presence of degradation products, an ultraviolet spectroscopic (UV) method for drug analysis has been developed. The pH 7.0 phosphate buffer was used as solvent. The amount of degraded drug was determined by taking the 230 nm absorbance. All products have been degraded under conditions of acidic, oxidation, photolytic and thermal degradation, and less degraded in alkaline conditions. In all conditions of degradation the tablet of brands Levocet and LECOPE showed less degradation than the brand name tablets Okacet-L and 1-AL. Keywords: Levocetirizine dihydrochloride, Degradation studies, Different brands, UV-spectrophotometer.

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