HPLC - METHOD DEVELOPMENT AND VALIDATION OF TREPROSTINIL FOR ESTIMATION IN PHARMACEUTICAL DOSAGE FORM

Abstract

Treprostinil was estimated using RP-HPLC in a simple, precise approach. Stationary phase Agilent C18 (250mm*4.6mm5m), mobile phase 0.01N Kh2po4: Acetonitrile in the ratio 60:40, flow rate 1.0ml/min, detection wave length 224nm, column temperature 30oC, and diluent mobile phase. Optimised conditions were set. System appropriateness characteristics were studied by injecting the standard six times and scoring considerably below acceptability. R2 was 0.999 for linearity study between 25% and 150%.Precision was 0.3 for repeatability and moderate precision.LOD and LOQ are 0.11μg/ml and 0.33μg/ml. The aforesaid approach assayed commercial formulation and found 99.45%. All Treprostinil degradation investigations showed purity thresholds greater than purity angle and within acceptable limits. Full length procedure was not conducted; if done, it can be utilised for regular Treprostinil analysis.