본문 바로가기
HOME> 논문 > 논문 검색상세

논문 상세정보

Analytical method development and validation for the analysis of verapamil hydrochloride and its related substances by using ultra perfomance liquid chromatography

Vijayabaskar, S. ; Mahalingam, V. ; Kalaivani ;
  • 초록  

    A novel, economic, and time-efficient stability-indicating, reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method has been developed for the analysis of verapamil hydrochloride in the presence of both impurities and degradation products generated by forced degradation. When verapamil hydrochloride was subjected to acid hydrolysis, oxidative, base hydrolysis, photolytic, and thermal stress, degradation was observed only in oxidative and base hydrolysis. The drug was found to be stable to other stress conditions. Successful chromatographic separation of the drug from impurities formed during synthesis and from degradation products formed under stress conditions was achieved on a Shimpak XR ODS, 75mmx3.0mm, 1.7μ particle size column, UV detection at 278nm and a gradient elution of ammonium formate, orthophosphoric acid and acetonitrile as mobile phase. The method was validated for specificity, precision, linearity, accuracy, robustness and can be used in quality control during manufacture and for assessment of the stability samples of verapamil hydrochloride. To the best of our knowledge, a validated UPLC method which separates all the sixteen impurities disclosed in this investigation has not been published elsewhere. Total elution time was about 18min which allowed quantification of more than 100 samples per day. The analytical method discussed in British Pharmacopeia was pH sensitive and not compatible to LC-MS analysis but the method reported in this study is not involved any pH adjustment.


  • 주제어

    Verapamil hydrochloride .   Impurities .   Degradation products .   Validation.  

 활용도 분석

  • 상세보기

    amChart 영역
  • 원문보기

    amChart 영역

원문보기

무료다운로드
  • 원문이 없습니다.

유료 다운로드의 경우 해당 사이트의 정책에 따라 신규 회원가입, 로그인, 유료 구매 등이 필요할 수 있습니다. 해당 사이트에서 발생하는 귀하의 모든 정보활동은 NDSL의 서비스 정책과 무관합니다.

원문복사신청을 하시면, 일부 해외 인쇄학술지의 경우 외국학술지지원센터(FRIC)에서
무료 원문복사 서비스를 제공합니다.

NDSL에서는 해당 원문을 복사서비스하고 있습니다. 위의 원문복사신청 또는 장바구니 담기를 통하여 원문복사서비스 이용이 가능합니다.

이 논문과 함께 출판된 논문 + 더보기