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Abstract

METHOD DEVELOPMENT AND VALIDATION, IMPURITY PROFILE OF (SPIKE STUDY) OF DOXYLAMINE SUCCINATE: A RESEARCH

Ms. Neha Gangurde*, Mrs. Itishree Vaidya, Mrs. Anita Ayre

ABSTRACT

A Rapid, simple and validated high performance liquid chromatography method has been developed for analysis of Doxylamine Succinate in pure powder form. Doxylamine Succinate was separated on silica analytical column(15cm ) with 70:30 (v/v) mix of Buffer (contain 100mM pH 4 acetate buffer ) and acetonitrile as mobile phase at flow rate 1 ml/min. The effluent was monitered by UV detection at 260 nm. and its validated with different parameter and its done with impurity profiling of a sample A and B with the spike study with drug also.

Keywords: HPLC, Chromatography, UV detection, Buffer.


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