Abstract

Objective: A simple, sensitive, robust method for the estimation of zaltoprofen was developed and validated. The forced degradation study was carried out as per FDA guidelines.

Methods: The method was developed by using HPLC Binary Gradient System (Model no.: HPLC 3000 Series) of Analytical Technologies Ltd. equipped with the UV-3000-M detector, P-3000-M Reciprocating (40MPa) Pump, Grace C18 (250mm x 4.6ID, Particle size: 5 microns) Column. The mobile phase optimized for the analysis of Zaltoprofen was Methanol and water in the ratio of 90:10 v/v having pH 3.The RT obtained for Zaltoprofen was 4.6 min. The Zaltoprofen was determined at 227nm.

Results: The linearity range was found to be 10-50 µg/ml with R2 0.997. The LOD and LOQ were found to be 0.1125µg/ml and 0.3409µg/ml respectively. The results of robustness and ruggedness were within the acceptable limit. The results of recovery were 99.80,99.84,99.74%. Forced degradation of Zaltoprofen was carried out by exposing to 0.1N HCL, 0.1N NaOH at 60°C for 30min., an oxidizing agent (3% H2O2), at 24 hrs., photolytic degradation study for 24 hrs., and thermal degradation at 600 °C for 24 hrs. The results of which were 9.08, 16.78, 6.4, 2.1, 3.46% degradation, respectively.

Conclusion: The method is economical and can be implemented for routine analysis of Zaltoprofen in bulk and tablet formulation. Forced degradation study will be useful for the determination of stability indicating properties of zaltoprofen.

Keywords: Zaltoprofen, HPLC, validation, forced degradation, bradykinin, chromatographic.

Graphical Abstract