A RAPID AND SENSITIVE VALIDATED HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY METHOD FOR DETERMINATION OF RELATED SUBSTANCES IN METOPROLOL SUCCINATE (API)

Rajendra Phadke* and Dr. Amit Gosar

ABSTRACT

The purpose of this research study is to develop simple, precise, accurate and economical method for determination of related substances in Metoprolol Succinate API. The chromatographic method was developed on Durashell C18, (250 mm x 4.6 mm, 5 μm) column with binary gradient system and the mobiles phase used for speperation was (a) Dipotassium hydrogen phosphate buffer with pH 3.0 ± 0.05 adjusted with ortho phosphoric acid and mobile phase (b) was mixture of 5 volumes of Acetonitrile, 4 volumes of Methanol and 1 volume of Water. The detection of all related substances observed at lower walength 223 nm and The peak response of all related substances are very good, all impurities were detected at about 0.112ppm and quitified at 0.340ppm.The relative standard deviation of all impurities was below five percentage. Developed method was validated as per ICH guideline and found to be linear, accurate, specific, precise, and robust. The correlation coefficient of all the impurities was below 0.999 and impurites responces where liner from 0.340 ppm to 3.500 ppm. The obtained recovery of all the impurities between 90 to 110 percentage and solution stability of the sample solution was found to be stable up to 24 hrs, hence this method can be successfully applied for the determination of related substances in Metoprolol Succinate API.

Keywords: Metoprolol Succinate API, Binary Gradient, HPLC, method development, validation.