ABSTRACT
A novel stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of purity of desloratadine in presence of its impurities and forced degradation products. The method was developed using Waters Aquity BEH C18 column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 280nm. The run time was 8min within which desloratadine and its five impurities were well separated. Desloratadine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Desloratadine was found to degrade significantly in oxidative and thermal stress conditions and stable in acid, base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, thus proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of desloratadine in pharmaceutical dosage forms.
Subject(s)
Chemistry, Pharmaceutical/standards , Drug Contamination , Loratadine/analogs & derivatives , Chemistry, Pharmaceutical/methods , Chromatography, Liquid/methods , Chromatography, Liquid/standards , Dosage Forms/standards , Drug Stability , Loratadine/analysis , Loratadine/standards , Pharmaceutical Solutions/analysis , Pharmaceutical Solutions/standardsABSTRACT
A simple and selective LC method is described for the determination of desloratadine in drug substance and pharmaceutical preparations. Chromatographic separation was achieved on a Diamonsil BDS C18 column using a mobile phase of a mixture of methanol, 0.03 mol/l heptanesulphonic acid sodium and glacial acetic acid (70:30:4, v/v) at a flow rate of 1.0 ml/min with detection at 247 nm. The developed method was validated in terms of selectivity, linearity, limit of quantitation, precision, accuracy and solution stability. The proposed LC method achieved satisfactory resolution between desloratadine and loratadine possibly present in desloratadine drug substance and other impurities in the mother liquor of the synthetic process. It can be used for the synthetic process control and determination of desloratadine in drug substance and pharmaceutical preparations.
Subject(s)
Chromatography, Liquid/methods , Loratadine/analogs & derivatives , Pharmaceutical Preparations/analysis , Calibration , Chromatography, Liquid/instrumentation , Loratadine/analysis , Loratadine/chemistry , Loratadine/standards , Reference Standards , Reproducibility of Results , Tablets , Technology, Pharmaceutical/methodsABSTRACT
The efficacy of loratadine as prophylactic therapy for seasonal allergic rhinitis was evaluated in a randomized, double-blind, parallel group, placebo-controlled study. One hundred eighteen subjects received either loratadine, 10 mg once daily, or placebo for 6 weeks. Treatment was begun prior to the onset of grass pollen seasonal symptoms of allergic rhinitis. Total symptom-free days occurred more frequently in subjects receiving loratadine. More loratadine than placebo subjects (65% versus 49%) had no symptoms or mild rhinitis at the end of the study. In contrast, the differences between loratadine and placebo in symptom scores did not achieve significance. The incidence of sedation and anticholinergic effects were comparable between the groups. Prophylactic loratadine therapy was effective in suppressing symptoms of seasonal allergic rhinitis and providing patients with symptom-free days throughout the pollen season.
Subject(s)
Loratadine/standards , Rhinitis, Allergic, Seasonal/prevention & control , Adolescent , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Loratadine/adverse effects , Loratadine/therapeutic use , Male , Middle Aged , Rhinitis, Allergic, Seasonal/drug therapy , Time FactorsABSTRACT
This study was designed to compare the efficacy and safety of loratadine and astemizole for the treatment of seasonal allergic rhinitis. A total of 167 adult patients with seasonal allergic rhinitis was enrolled in a randomized double-blind, parallel group study. Patients were treated once daily for 2 months during a spring allergy season. Both treatment groups showed significant reduction of symptoms (P < .01) from baseline. The physicians' and patients' evaluations of response to treatment were generally higher for loratadine than astemizole but only reached statistical significance (P < .05) at the 1-week evaluation. Astemizole-treated patients showed statistically significantly more weight gain than did loratadine-treated patients. Loratadine and astemizole were comparable in reducing the signs and symptoms of seasonal allergic rhinitis. Both treatments were well tolerated, although less weight gain was observed in patients treated with loratadine.
