Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE IN OPHTHALMIC SOLUTION BY RP-HPLC

Adiandra Anantha Kumar*, K. Thejomoorthy and P. Sreenivasa Prasanna

ABSTRACT

Objective: An accurate and precise HPLC method was developed for the determination of Dorzolamide HCl and Timolol Maleate in ophthalmic solution. Method: Separation of the drug was achieved on a INERTSIL ODS 3V 150x4.5 column using a mobile phase consisting of buffer and methanol in the ratio of 50:50v/v adjusted pH of 7.5. The flow rate was 1.0 mL/min and the detection wavelength was 276 nm. Results and conclusion: The linearity was observed in the range of 20-100 ppm for Dorzolamide and 5- ppm for Timolol with a correlation coefficient of 1.0 and 1.0 respectively. The proposed method was validated for its linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of Dorzolamide and Timolol in Ophthalmic solution.

Keywords: Dorzolamide HCl and Timolol Maleate, HPLC, Validation, Retention time.