Stability Indicating HPLC Method Development ...

Stability Indicating HPLC Method Development and Validation for the Simultaneous Estimation of Tropicamide, Phenylephrine Hydrochloride and Lidocaine Hydrochloride Injection

Author Name : Awasthi Mansi, Mr. Ketan S Rathod, Ms. Vanita Marvaniya, Dr. Alpesh D Patel

ABSTRACT

A high-performance liquid chromatography method was developed for simultaneous estimation of Tropicamide, Phenylephrine Hydrochloride, Lidocaine Hydrochloride injection. Stability indicating assay method of Tropicamide, Phenylephrine Hydrochloride, Lidocaine Hydrochloride injection by HPLC has been developed and validated using Shimadzu HPLC System and Acetate Buffer (pH 4.4): Acetonitrile (40:60) was used as mobile phase at 1.0 ml/min flow rate and response detected at 234 nm in 10minute run time. The Retention time of Tropicamide, Phenylephrine Hydrochloride, Lidocaine Hydrochloride were found to respectively 7.4, 9.0 and 12.6 minutes. Method was linear in the range of 5-30 µg/ml (r2 = 1) % Recovery at 80%, 100% and 120% were in acceptance limit near to 80%. The % RSD for Repeatability of Tropicamide, Phenylephrine Hydrochloride and Lidocaine Hydrochloride were 0.04%, 0.10% and 0.02% respectively. The %RSD for robustness was in between 0.08-0.03% acceptance limit for drug. Stability data of formulation is also good. Validation of developed HPLC were found simple, specific, accurate, rapid, precise, economical and reliable for contemporary analysis of drugs in injection and also study the force degradation of their combine dosage form. The proposed method was successfully applied for the simultaneous estimation of all these three drugs in Commercial dosage form

Key Words: Tropicamide, Phenylephrine Hydrochloride, Lidocaine Hydrochloride, HPLC Method, Stability, Validation