Open AccessValidated HPLC Method for Assay and Content Uniformity Testing of Roflumilast in Blend and Tablets
Author(s) -
Nukendra Prasad Nadella,
R. Venkata Nadh,
Navuluri Srinivasu
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22373
Subject(s) - roflumilast , chromatography , chemistry , high performance liquid chromatography , chronic bronchitis , correlation coefficient , content determination , pulmonary disease , medicine , mathematics , statistics
Roflumilast is a selective enzyme inhibitor of phosphodiesterase-4. This drug is recommended fortreatment of patients suffering from chronic-obstructive-pulmonary-disease with chronic-bronchitis.Roflumilast is not official in pharmacopoeia and the reported methods are having high chromatographicrun times. A short run time HPLC method was developed for assay and content uniformity testing todetermine the roflumilast in blend and tablets. The mobile phase consists of 10 mM sodium dihydrogenphosphate monohydrate buffer and acetonitrile in the ratio of 45:55 v/v. The HPLC method wasdeveloped using accucore-C18 150 × 4.6 mm, 4 μm column with a flow rate of 1.0 mL min-1, 215 nmwavelength and 10 μL injection volume with run time of 5 min. The method linearity was provedbetween 5.02-40.17 μg mL-1 and obtained correlation-coefficient value is 1.0000. The mean recoveryof roflumilast was 100.6%. The stability indicating nature was established and performed the validationby considering ICH Q2 (R1) recommendations.