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 H 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.
Highlights
IntroductionLevocetirizine dihydrochloride (LCT), (-)-cetirizine dihydrochloride; 2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride, (Figure 1) is a third generation non sedative antihistamine, H1-receptar antagonist and is the active enantiomer of cetirizinedihydrochloride. 1–4 It is used to treat seasonal or perennial allergic rhinitis and chronic idiopathic urticarial. 5–7
Levocetirizine dihydrochloride (LCT), (-)-cetirizine dihydrochloride; 2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride, (Figure 1) is a third generation non sedative antihistamine, H1-receptar antagonist and is the active enantiomer of cetirizinedihydrochloride. 1–4 It is used to treat seasonal or perennial allergic rhinitis and chronic idiopathic urticarial. 5–7Analysis is an essential component in the formation of any drug molecule in formulation
According to International Conference on Harmonization (ICH) guidelines, the active pharmaceutical ingredient is subject to a range of forced degradation conditions, including acidic, basic, hot liquid, photolytic and oxidative conditions. 10
Summary
Levocetirizine dihydrochloride (LCT), (-)-cetirizine dihydrochloride; 2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride, (Figure 1) is a third generation non sedative antihistamine, H1-receptar antagonist and is the active enantiomer of cetirizinedihydrochloride. 1–4 It is used to treat seasonal or perennial allergic rhinitis and chronic idiopathic urticarial. 5–7. According to ICH guidelines, the active pharmaceutical ingredient is subject to a range of forced degradation conditions, including acidic, basic, hot liquid, photolytic and oxidative conditions. liquid chromatography (LC), reverse phase high performance liquid chromatography (RP-HPLC), 7 methods for quantification of LCT in human plasma and pharmaceutical dosage form. These methods involve difficult sample preparation and long chromatographic run time with an organic phase and different buffer proportions. It is even more difficult and timeconsuming to determine the stress-degraded behaviour of LCT. The main aim of this work is to study LCT’s stability behaviour using simple UV-spectrophotometric method
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