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Abstract

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF KETOTIFEN AND SALBUTAMOL IN BULK AND DOSAGE FORM

*Raval Kashyap, U. Srinivasa

ABSTRACT

A simple, accurate and precise High Performance Liquid Chromatographic (HPLC) method has been developed for simultaneous determination of Ketotifen and Salbutamol in bulk and dosage form. The method has been validated as per the guidelines of ICH. The separation is achieved on 250*4.6mm C18, 5micron (Hypersil BDS) column with flow rate 1.0 mL per minute in isocratic mode using Buffer pH 3.5(0.1% triethylamine): Acetonitrile(60:40) as mobile phase. Column oven temperature is maintained at 25°C. The linearity range was found to be in the range of 5-15 μg/ml for Ketotifen and 10-30 μg/ml for Salbutamol. Correlation co-efficient for calibration curve of Ketotifen and Salbutamol was found to be 0.9988 and 0.9989 respectivelyThe method is simple, accurate, reproducible and short and can be used for simultaneous analysis of Ketotifen and Salbutamol.

Keywords: Ketotifen, Salbutamol, Buffer pH 3.5 and Acetonitrile.


[Full Text Article]

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