Investigation of the long-term stability and forced degradation of valtrate by high performance liquid chromatography coupled with triple quadrupole tandem mass spectrometry

doi:10.5246/jcps.2014.12.108

Journal of Chinese Pharmaceutical Sciences ›› 2014, Vol. 23 ›› Issue (12): 850-857.DOI: 10.5246/jcps.2014.12.108

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Investigation of the long-term stability and forced degradation of valtrate by high performance liquid chromatography coupled with triple quadrupole tandem mass spectrometry

Feifei Wang^1†, Mingjuan Wang^1†, Yumei Zhang¹, Yan Wang¹, Jiandong Yu¹, Ruizhong Wang¹, Xianlong Cheng¹, Qi Wang¹, Xiaowei Zheng¹, Yan Liu¹, Zhong Dai^1*, Shuangcheng Ma^1*, Erwin Adam²

1. National Institutes for Food and Drug Control, Beijing 100050, China
2. Katholieke Universiteit Leuven, Faculteit Farmaceutische Wetenschappen, Laboratorium voor Farmaceutische Analyse, PB 923, Herestraat 49, B-3000 Leuven, Belgium

Received:2014-08-05 Revised:2014-09-24 Online:2014-12-25 Published:2014-09-29
Contact: Tel.: 86-10-67095896
Supported by:
Special Funds of the National Natural Science Foundation of China on “Major New Drugs Innovation and Development” (Grant No.2014ZX09304307-002).

Abstract

Abstract:

Valtrate is the main drug quality control for the qualitative and quantitative analysis of Valerian medicines in the Chinese Pharmacopoeia 2010.However, valtrate is unstable under some conditions. We, for the first time, systemically evaluated the stability of two bath reference standards (RS) by high performance liquid chromatography coupled with a triple quadrupole mass spectrometer(HPLC-MS/MS).The forced degradations of valtrate were performed to evaluate its optimal storage, transportation and experiment conditions according to ICH guideline.The developed HPLC method was validated to determine the degradation products. Valtrate RS was sensitive to alkaline and thermal conditions, but it was relatively stable under acidic, oxidation and photolysis conditions. A total of nine degradation components were identified under alkaline hydrolysis (N1–N4) andthermal degradation (B1–B5). The information obtained in this work would be valuable to minimize the decomposition of valtrate during the processes of preparation,storage, distribution and utilization. It was highly suggested to store valtrate with a single dose packing in brown closed ampoule at –20 ºC. Under the above-mentioned storage condition, valtrate could be stable for up to 3 years.

Key words: Valtrate, Stability, Long-term stability, Forced degradation, Tandem mass spectrometry

CLC Number:

R917

Supporting:

Feifei Wang, Mingjuan Wang, Yumei Zhang, Yan Wang, Jiandong Yu, Ruizhong Wang, Xianlong Cheng, Qi Wang, Xiaowei Zheng, Yan Liu, Zhong Dai, Shuangcheng Ma, Erwin Adam. Investigation of the long-term stability and forced degradation of valtrate by high performance liquid chromatography coupled with triple quadrupole tandem mass spectrometry[J]. Journal of Chinese Pharmaceutical Sciences, 2014, 23(12): 850-857.

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Investigation of the long-term stability and forced degradation of valtrate by high performance liquid chromatography coupled with triple quadrupole tandem mass spectrometry

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