Determination of Stavudine and Related Substances by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a HPLC method for the determination of stavudine and related substances METHODS:The Hypersil C18(4 6mm?150mm,5?m)was used as analysis column The mobile phase was methanol-water(13∶87,V/V) Detection wavelength was 264nm The flow rate was 1ml/min The column temperature was 20℃ RESULTS:The calibration curves was linear in the concentration range of 0 025～0 3mg/ml(r=0 9 999,n=6) The average recovery was 99 26%(RSD=0 76%) The contents of stavudine in 3 batches of semifinished materials and stavudine capsules(imported and domestic)were 99 48%,99 55%,99 32%(materials);97 21%,101 54%,98 92%(imported stavudine capsule);100 57%,97 86%,102 33%(domestic stavudine capsule)respectively CONCLUSION:The method is simple,accurate,sensitive and repeatable and it is suitable for the determination of stavudine and its preparations