ファーマシューティカ アナリティカ アクタ

概要

Development and Validation of Stability- Indicating Tlc-Densitometric Determination of Ropinirole Hydrochloride in Bulk and Pharmaceutical Dosage Form

SB Bari, AR Bakhshi, PS Jain and SJ Surana

A TLC/densitometry of ropinirole hydrochloride as a bulk drug was developed and validated.The separation was achieved on TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase using chloroform: acetone: triethylamine (3.5:1.5:0.2 v/v) as mobile phase and densitometry analysis at 250 nm. The system showed compact spot for ropinirole hydrochloride (R f = 0.52 ± 0.02). The drug follows linearity in the concentration range 300 - 1800 ng per band (r 2 = 0.9983 ± 0.0008). Drug was subjected to hydrolysis, oxidation and thermal degradation which indicate the drug is susceptible to hydrolysis, oxidation and heat and degraded product did not interfere with detection and assay of ropinirole hydrochloride. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of ropinirole hydrochloride.