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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