Abstract

Ultra violet spectrophotometric method for the estimation roflumilast in spiked human serium. The present study was spectrophotometric estimation of roflumilast in spiked human serum is based on measurement at the maximum wavelength 248 nm using 0.2M Hcl as a solvent. The roflumilast stock solution was prepared with distilled water to produse calibration curve. The standard solution of roflumilast shows absorption maxima at 248 nm. The roflumilast obeyed beer lamberts law in the concentration range of 40-88μg/ml with regression 0.9987 at 248nm. The overall percentage recovery of roflumilast was found to be 99.52% which reflects that the method was free from the interference. The % RSD values of intra day and inter day precision was found to be 0.031 and 0. 046% respectively, which is less than 2 and hence this method is precise. The values of LOD and LOQ were found to be 0.783 and 2.375 μg/ml, respectively and it indicates this method was sensitive.

Highlights

  • Roflumilast (Figure 1) is a chemically3-(cyclopropylmethoxy)-N(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy) benzamide and it is a selective, long acting phosphodiesterase-4 inhibitor

  • Materials Blank human serum, Roflumilast sample (99.90% purity) was purchased from Spectrum Pharma Research Solutions, Hyderabad, India

  • Method validation The developed method was validated for various parameters like linearity, precision, accuracy, limit of detection, limit of quantitation, robustness and ruggedness according to ICH guidelines

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Summary

Introduction

Roflumilast (Figure 1) is a chemically3-(cyclopropylmethoxy)-N(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy) benzamide and it is a selective, long acting phosphodiesterase-4 inhibitor. Roflumilast; Method development; and precise for estimation of roflumilast in spiked human serum by using UV spectroscopy. Method development Preparation of standard solution: A standard stock solution was prepared by accurately weighed 1000 mg of roflumilast in 1000ml of volumetric flask and dissolved in 0.2M of Hcl to obtain a concentration 1000 μg/ml.

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