Stability Indicating RP-HPLC Method Developme...

Stability Indicating RP-HPLC Method Development and Validation for The Simultaneous Estimation of Etoricoxib And Tolperisone HCl In Pharmaceutical Dosage Form

Author Name : Pandey Sakshi Dayanath, Ms. Seju Patel, Ms. Vanita Marvaniya, Dr. Alpesh D Patel

ABSTRACT

Objectives: A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for Etoricoxib and Tolperisone HCl in its Pharmaceutical Dosage Form has been developed.

Methods: The separation was achieved by Hypersil ODS C18 (250 mm × 4.6 mm, 5µm) column and 0.02 M Ammonium Acetate Buffer: Acetonitrile: Methanol (50:30:20) as mobile phase, at a flow rate of 0.8 ml/min. Detection was carried out at 210 nm.

Result: Retention time of Tolperisone HCl was found to be 2.887 min. and Etoricoxib was found to be 16.467 min. The method has been validated for linearity, accuracy and precision. Linearity observed for ETO 3-15 μg/ml and for TOL 7.5-37.5 μg/ml. Developed method was found to be accurate, precise and rapid for estimation of Etoricoxib and Tolperisone HCl in its Pharmaceutical Dosage Form. Various forced degradation conditions such as acid hydrolysis, base hydrolysis, photolytic and oxidative degradation were applied to the marketed formulation.

Conclusion: The aim of the present study is to develop sensitive, simple, rapid, economical, precise and accurate derivative spectrophotometric method to determine Etoricoxib and Tolperisone HCl in Pharmaceutical Dosage Form. The validation parameters indicate that drug substances were efficiently separated from its degradants and developed method can be applied for simultaneous estimation of Etoricoxib and Tolperisone HCl in Pharmaceutical dosage form.

Keywords: Etoricoxib, Tolperisone HCl, Stability indicating RP-HPLC Method,  Stability, Validation.