ABSTRACT
Objective: To develop and validate a simple, selective, precise and accurate method for the estimation of rupatadine fumarate in bulk and tablet dosage form by using the single point standardization method as per international conference on harmonization (ICH) guidelines. Methods: In this proposed method, the absorbance of a standard solution of known concentration and a sample solution was measured. From this, the concentration of the unknown can be calculated. Results: Rupatadine fumarate showed maximum absorbance at 246 nm with methanol. Linearity was checked in different concentrations. The calibration curve was obtained in the range of 2-10 µg/ml. The slope, intercept and correlation coefficient (R2) values of Rupatadine fumarate were found to be 0.047, 0.0034 and 0.9995 respectively. Intra-day and inter-day precision studies were carried out and there % RSD values were found within limits i.e. less than 2%. The recovery studies were carried out by adding a known amount of standard drug to preanalysed formulation and % Recovery was found to be within 99.7-101.6%. LOD and LOQ of Rupatadine fumarate were found to be 0.1 µg/ml and 0.3 µg/ml respectively. Robustness studies were performed at different wavelengths and the % RSD was found within the limits i.e. less than 2 %. Conclusion: The developed single point standardization method for the estimation of Rupatadine fumarate was found to be simple, precise, accurate, reproducible and cost-effective. Statistical analysis of the developed method confirms that the proposed method is an appropriate and it can be useful for the routine analysis. The proposed method gives the basic idea to the researcher who is working in the area like product development.
ABSTRACT
Aim: To compare the therapeutic efficacy and safety of Rupatadine and mometasone with Levocetirizine which is most commonly used drug.To study the effects of levocetirizine, Rupatadine and mometasone on absolute eosino-phil count and IgE levels. Methodology:The participants were randomlydivided into 3 groups of 25 patients each and treated as follows: Group I: were treated with Levocetirizine 5mg OD for 14 days, Group II: were treated with Rupatadine 10mg OD for 14 days, Group III: were treated with Mometasone two sprays (50mcg of mometasone in each spray) in each nostril once daily (total daily dose of 200mcg) for 14 days. The patients were asked to report at the hospital after 14 day and they were followed up with regard to clinical improvement of symptoms and signs and any adverse effects as reported by the patient. Rhinoscopy finding, X-ray of para nasal sinus, improvement in symp-toms (sneezing, Itching, nasal discharge, nasal blockage and anosmia) Absolute eosinophils count, Serum IgE levels and adverse reports were studied and investigation were compared before and after treatment. Result: Rhinoscope finding showed treatment with mometasone became normal but X-Ray of para nasal sinus results showed levocetir-zine showed higher rate of improvement. In improvement of symptoms sneezing, itching and nasal discharge was high mometasone. In all groups post treatment there was no changes in Ig E and Absolute Eosinophil’s count. ADR reported with mometaxone. Conclusion: The three drugs, levocetirizine, rupatadine and mometasone were found to have similar levels of efficacy in controlling the symptoms of the allergic rhinitis. The physical signs improved better with mometasone than the other 2 drugs. The 3 drugs levocetirizine, rupatadine and mometasone had no significant effect on the absolute eosinophil count and the serum IgE levels. Adverse effects were found to be more with levoce-tirizine than the other two drugs. Considering this factor and also the fact that long term use of corticosteroids like mometasone is undesirable, rupatadine appears to be a better choice in the treatment of allergic rhinitis.
ABSTRACT
Objective:To determine the content of cyclohexane, ethyl acetate, methanol, methylene chloride and trichloromethane in rupatadine fumarate by headspace gaschromatography. Methods:A DB-WAXETRR capillary column(30 m × 0. 32 mm,0. 25 μm)was used and the carrier gas was nitrogen. The detector was an FID and the inlet temperature was 200℃ . The column temperature program was with the initial temperature of 35℃,maintained 10 min,and then risen to 220℃ with the rate of 20℃·min -1 ,and maintained 5 min. Results:Cyclohexane,ethyl acetate,methanol,methylene chloride and trichloromethane showed a good linear relationship within the range of 77. 590 1- 698. 310 9 μg·ml -1(r = 0. 999 7),102. 166 6- 919. 499 4 μg· ml -1(r = 0. 999 8),62. 744 7- 564. 703 2μg·ml -1(r = 0. 999 9),12. 011 2- 108. 101 1 μg·ml-1(r = 0. 999 6)and 1. 262 8-11. 365 6 μg·ml -1(r = 0. 999 6). The average recovery was 103. 9% ,103. 5% ,104. 9% ,107. 1% and 103. 4% and RSD was 2. 3% ,2. 6% ,3. 1% ,2. 8% and 4. 5%(n = 9),respectively. The five residual solvents were not detected out in rupatadine fumarate. Conclusion:The method is stable,simple,sensitive and accurate,and can be used for the determination of residual solvents in rupatadine fumarate.