Estimation of olopatadine hydrochloride by RP–HPLC and U.V spectrophotometry method in pure and pharmaceutical formulation

Abstract

A simple and sensitive Reversed Phase High Performance Liquid Chromatographic method and UV Spectrophotometry
has been developed and validated for the of the Olopatadine Hcl in pure and pharmaceutical dosage form. In RP-HPLC
Method the separation was carried out using mobile phase consisting of Methanol and Acetonitrile in the ratio of 60:40
(v/v). The column used was inertsil ODS 3V C18, (250 mm x 4.6 mm i.d., 5μm) with flow rate 1.2ml/min using UV
detection at 254 nm. The method was linear over a concentration range of 10 – 250μg/. The retention time of 2.857min.
Results of analysis were validated statistically and by recovery studies. The mean recovery was 98.2 to101.5. The limit
of detection (LOD) and the limit of quantification (LOQ) were found to be 0.024 and 0.075μg/ml. The %RSD for the
method precision was found to be less than 2%. To develop simple and economical UV spectrophotometric method for
the estimation of Olopatadine in pharmaceutical dosage form available in the market for conjunctivitis.The method was
validated as per the ICH guidelines and the results were statistically validated. Linearity was observed in concentration
range of 10-60μg/ml for Olopatadine. The accuracy of the method was evaluated by recovery studies and good recovery
results were obtained between 98% to 100% and the relative standard deviation was found to be below 2% . A simple,
accurate, sensitive and economical UV-spectrophotometric method for the estimation of Olopatadine pharmaceutical
dosage form has been developed which can be employed in the industry for the routine analysis.