Determination method of related substances in risedronate sodium tablets / 药学实践杂志
Journal of Pharmaceutical Practice
; (6): 40-43, 2015.
Article
em Zh
| WPRIM
| ID: wpr-790402
Biblioteca responsável:
WPRO
ABSTRACT
Objective To establish a HPLC method for determination of related substances of risedronate sodium tab‐lets .Methods The C18 column ,5 μm ,150 mm × 4 .6 mm ,the buffer solution (3 .22 g tetrabutyl ammonium bromide was added to a buffer solution of 1 000 ml 0 .05 mol/L ammonium chloride ,then adjusted pH to 7 .8 ± 0 .05 by ammonia)‐methanol‐aceto‐nitrile =2505025 as mobile phase ,column temperatureroom temperature ,flow rate1 .0 ml/min ,detection length254 nm . Results Determined by HPLC at high temperature ,acid ,alkali degradation ,the main peak and the impurity peaks were separa‐ted well ,and the peaks had a linear relationship ,Y=1 .28 × 107 X-1 .62 × 105 (r=0 .999 9) .Conclusion The method was rap‐id ,simple ,accurate and sensitive ,and suitable for determination of risedronate sodium tablets related substances .
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1
Índice:
WPRIM
Idioma:
Zh
Revista:
Journal of Pharmaceutical Practice
Ano de publicação:
2015
Tipo de documento:
Article