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Bioanalytical Method Development and Validation for Latanoprost Quantification in Pharmaceutical Opthalmic Microemulsion Formulation by RP-HPLC

Pratikeshkumar Patel, Priti Patel and Prabhanjan Giram

A novel HPLC method has been developed and validated for the determination of Latanoprost in pharmaceutical ophthalmic formulation for in-vivo and ex-vivo animal studies. The method used a Supelco analytical C18 (250 mm × 4.6 mm i.d., 5 μm particle size) column, under the following chromatography conditions: Isocratic elution, using a mobile phase composed by consisting of acetonitrile as an organic modifier and water of 60:40 (v/v). The mobile phase was delivered at a flow rate of 1 ml/min and the detection was made by Ultraviolet (UV) detector at 210 nm. This method was fully validated and applied to available pharmaceutical product. The limit of detection (LOD) and limit of quantitation (LOQ) for Latanoprost were 0.07 μg/ml and 0.019 μg/ml respectively. The purpose of this method analysis of marketed and developed ophthalmic formulations of Latanoprost. This method can be used for quality control assay of Latanoprost in materials as well as in pharmaceutical formulations.