Abstract：Objective To evaluate the consistency of related substances between the domestically marketed Difenidol Hydrochloride Tablets and reference preparations.Methods The related substances of Difenidol Hydrochloride Tablets were determined and evaluated according to the official quality standard recorded in Pharmacopoeia of the People′s Republic(2015 edition,version 2).The forced degradation test was also carried out.Results The detection limit of impurityⅠwas 2.8 ng,and the quantitative limit was 9.7 ng.The solution of Difenidol Hydrochloride was stable in 18 hours,and the relative standard deviation (RSD)of impurities and main peak area was less than 2%.The linearity range of impurityⅠwas 0.4829-48.2900μg/ml(R2=1).In the precision test of impurityⅠ,the RSD of peak area was 4.2%(n=12).The average recovery of impurityⅠ(n=6)was 102.6%,and RSD was 2.0%.No impurities were detected in two batch tablets of the first domestic manufacturer.The content of impuritiesⅠwas 0.14%in another batch.No impurities were detected in two batch tablets of the original manufacturer.The content of impuritiesⅠwas 0.10%in another batch.The content of impuritiesⅠwas among 0.2%-0.5%in the other three domestic manufacturers′tablets.Under the conditions of light,oxidation,heat and alkaline damage,there was no significant change in the related substances between the first domestic imitator and the original manufacturer′s tablets.Under the acid damage condition,the degradation of the main peak was 15%,and the increase of impurityⅠwas 15%.Conclusion Impurity profiling of the first generic preparations is consistent with the reference preparations.For other three domestic manufacturers,impurityⅠcontent is 2-5 times higher than that of the reference preparations.
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