A New RP-HPLC Method for Determination of Roflumilast in Bulk and Pharmaceutical Dosage Forms

[摘要] Background: Rofumilast drug estimation was done earlier by spectroscopic methods. Only few chromato graphic studies were reported. Objective: Development and validation of RP-HPLC method for the drug Roflumilast by using various chromatographic parameters. Methodology: RP-HPLC method was developed with 1 ml/min as flow rate and 10 µl was set as volume of injection for about 15 minutes of run time. Various parameters like accuracy, linearity, precision were validated for the method as per ICH guidelines.Results: UV detection for maximum wavelength at 250 nm with mobile phase of 30:70 ratio of Trifluroacetic acid (pH 3.2): Acetonitrile showed the retention time of 2.317 min. Conclusion: The proposed RP- HPLC method was found to be rapid, simple, precise, accurate and economic forestimation of roflumilast in bulk and pharmaceutical formulations. Background: Rofumilast drug estimation was done earlier by spectroscopic methods. Only few chromato graphic studies were reported. Objective: Development and validation of RP-HPLC method for the drug Roflumilast by using various chromatographic parameters. Methodology: RP-HPLC method was developed with 1 ml/min as flow rate and 10 µl was set as volume of injection for about 15 minutes of run time. Various parameters like accuracy, linearity, precision were validated for the method as per ICH guidelines.Results: UV detection for maximum wavelength at 250 nm with mobile phase of 30:70 ratio of Trifluroacetic acid (pH 3.2): Acetonitrile showed the retention time of 2.317 min. Conclusion: The proposed RP- HPLC method was found to be rapid, simple, precise, accurate and economic forestimation of roflumilast in bulk and pharmaceutical formulations.

[学科分类] 药学、药理学、毒理学（综合）

[关键词] Roflumilast;HPLC;UV;ICH