HPLC analysis of orlistat and its application to drug quality control studies.
In this study, a high performance liquid chromatography method with UV detection was developed for determination of orlistat. The chromatographic system consisted of a Nova-Pack C18 column, an isocratic mobile phase of phosphoric acid 0.1%-acetonitrile (10 : 90, v/v) and UV detection at 205 nm. Orlistat was eluted at about 6 min with no interfering peak from excipients used for preparation of dosage form. The method was linear over the range of 10-160 microg/ml orlistat (r2 > 0.9999). The within-day and between-day precision values were also in the range of 0.10-0.59%. The appropriate dissolution conditions were also determined and applied to evaluate the dissolution profile of orlistat capsules. Optimal conditions were 1000 ml of 3% SLS in water as dissolution medium and paddle at 100 rotation per minute. The proposed method was applied successfully to the determination of orlistat content in capsules and in vitro dissolution studies.
Souri
Effat
E
Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Jalalizadeh
Hassan
H
Kebriaee-Zadeh
Abbas
A
Zadehvakili
Bettina
B
D019440:Anti-Obesity Agents / Q000032:analysis*; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004355:Drug Stability; D007783:Lactones / Q000032:analysis*; D000077403:Orlistat; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013997:Time Factors
D019440:Anti-Obesity Agents; D002214:Capsules; D007783:Lactones; D000077403:Orlistat