Abstract

DEVELOPMENT AND VALIDATION OF THE UV- SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SALMETEROL XINAFOATE IN API AND PHARMACEUTICAL DOSAGE FORM

Rekha Pritishkumar Mudke*, Dr. Varsha Siddheshwar Tegeli and Sonali Narsing Koli

ABSTRACT

A rapid, simple, selective, sensitive, precise and specific UV Spectrophotometric method has been developed for the determination of Salmeterol Xinafoate in API and pharmaceutical dosage form. Salmeterol Xinafoate standard solution was scanned in the UV range (200-400nm) in 1cm quartz cell in a double beam UV Spectrophotometer. The spectrophotometric detection was carried out at an absorption maximum of 254 nm using Acetonitrile:Methanol (50:50) as a solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for the Salmeterol Xinafoate was linear over the selected concentration range 2-12 μg /ml with a correlation coefficient of 0.999 and equation for the regression curve was found to be y=0.0474x+ 0.0401. The accuracy was between 98.7-102%. The precision (%RSD) among six samples preparation was 0.459 %. The LOD and LOQ are 0.1056 And 0.3200 μg /ml respectively. Statistical analysis proved that the methods are repeatable and specific for the determination of the said drug. These methods can be adopted in the routine assay analysis of Salmeterol Xinafoate in API and pharmaceutical dosage form.

Keywords: Salmeterol Xinafoate, UV Spectrophotometer, Acetonitrile: Methanol (50:50), Method Validation.