HPLC method for the determination of salbutamol sustained-release capsules hydrochloride L-related substances.docVIP

 PAGE \* MERGEFORMAT 10 HPLC method for the determination of salbutamol sustained-release capsules hydrochloride L-related substances Study: Hong Deng Lin Huaqing Qi Xiao-Xiao Zhang Shu Yu Chuqin [Abstract] Objective To determine the L-salbutamol hydrochloride sustained release capsules related substances. Methods using high performance liquid chromatography (RP HPLC method), column was Kromasil C18 column (250 mm 4.6 mm, 5 m), methanol phosphate buffer solution (sodium dihydrogen phosphate 9.77 g, dissolved in water and diluted to 1 000 mL, adjusted with phosphoric acid to a pH value of 3.10 + -0.05 (volume ratio of 20:80 as mobile phase, detection wavelength was 224 nm, flow rate of 1.0 mL min-1. The results of the impurity peaks were separated well, L minimum detection limit of salbutamol 14 ng. Conclusion The method can be used for salbutamol hydrochloride sustained release capsules L-related substances detected. [Keywords:] L-salbutamol hydrochloride sustained-release capsules related substances by high performance liquid chromatography L Chiral Drugs salbutamol (levalbuterol, C13H21NO3) is a 2 adrenergic receptor agonists, can stimulate the bronchial smooth muscle of the 2 adrenergic receptor, selective relaxation of bronchial smooth muscle, the role of a bronchodilator for the treatment of asthma, wheezing bronchitis, emphysema patients with bronchospasm. racemic salbutamol as one of the enantiomers, compared with the racemic, L-salbutamol to produce adverse effects in addition to the D-body, its side effects reduced , effects are further enhanced [1]. At present, L-salbutamol aerosols have been listed abroad, China has not yet listed with L-salbutamol formulation, this paper is on the self-made L-salbutamol hydrochloride sustained-release capsules for quality control, systematic study its related substances influencing factors, and the establishment of the sustained-release capsules Determination of related substances, the method is simple