Abstract

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF ROFLUMILAST AND SALMETEROL IN SYNTHETIC MIXTURE

Patel Ushma B.* and Patel Paresh U.

Abstract

A simple, precise, sensitive, rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of the Roflumilast and Salmeterol in synthetic mixture. The stationary phase used was precoated silica gel 60F254 plate. The mobile phase used was a mixture of toluene: acetonitrile: triethayamine (6:3:1 v/v/v). The detection of spots was carried out densitometrically using a UV detector at 254 nm in absorbance mode. This system was found to give compact spots for Roflumilast (Rf value of 0.13) and Salmeterol (Rf value of 0.63). The method was validated according to ICH guidelines in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 200 to 1400 ng/spot for Roflumilast and 100-700 ng/spot for Salmeterol with significantly high value of correlation coefficient (r2 > 0.99). The limits of detection and limits of quantitation were found to be 161.74 and 35.59 ng/spot respectively for Roflumilast and 8.96 and 27.14 ng/spot respectively for Salmeterol. All the validation parameters were found to be within acceptable limits. The method was found to be rapid, cost effective, accurate and precise therefore be utilized for the routine analysis of both the drugs in synthetic mixture. The proposed method can be used in the quality control of both the drugs in synthetic mixture.

Keywords: Roflumilast, Salmeterol, HPTLC, Synthetic mixture, Validation.