HPLC determination of dopamine hydrochloride injection related substances.docVIP

 PAGE \* MERGEFORMAT 8 HPLC determination of dopamine hydrochloride injection related substances [Abstract] Objective To screen the appropriate HPLC conditions for determination of dopamine hydrochloride injection related substances. Methods without any correction factor principal component self-control method, using RP  HPLC; column was Diamonsil C18 (4.6 mm * 150 mm, 5 μ m); mobile phase [0.005 mol / mL sodium dodecyl sulfate  bing acetic acid  0.1 mol / mL disodium ethylene diamine tetra acetic acid (700:10:2)]  acetonitrile (6:4); column temperature: 40 ℃ ; flow rate: 1.20 mL / min; detection wavelength 280 nm. Results 1 ~ 12 μ g / mL range of good linearity was determined for the standard curve Y = 36493X-629.88 (r = 0.9996, n = 11); the minimum detection limit was 0.9997 ng. Conclusion This method is specific, accurate, sensitive and can be used to dopamine hydrochloride injection related substances inspections. [Keywords:] RP  HPLC method; dopamine hydrochloride injection; related substances Dopamine hydrochloride (dopamine hydrochloride) injection of the related substances of Chinese herbal medicine [1] and they have not received set. British Pharmacopoeia contained in closed sterile concentrated solution of dopamine and dopamine hydrochloride injection using thin-layer chromatography, need to use methyl dopamine hydrochloride reference substance (4  O  methyldopamine hydrochloride, and 3  O  methyldopamine hydrochloride) measurement system, the applicability of [ 2]. In this paper, HPLC method for related substances, methods, accuracy, good reproducibility, high sensitivity can be used as the product of the related substances inspection methods, more effective quality control of them. An instrument and reagent TU1901-type UV-Vis spectrophotometer, the United States Waters 1525 high-performance liquid chromatography, Japan, Shimadzu LC  10Avp high-performance liquid chromatography. Methanol, acetic acid, sodium dodecyl sulfate