Method Development And Validation For Hydroxyurea In Fixed Oral Solid Dosage Forms Using RPHPLC With DAD Detection

A simple isocratic Reverse Phase High Performance Liquid Chromatography (RP-HPLC)method was developed and validated for the determination of Hydroxyurea in two different oral solid dosage forms (tablets and Capsules). The strength of samples were 100 mg, 200 mg, 300 mg and 400 mg. The method consists of a mobile phase combination of methanol (HPLC grade) and a salt solution (1.7 g quantity of tetrabutylammonium hydrogen sulphate and 1.74 g of dibasic potassium phosphate anhydrousdiluted to 1L with pH adjusted to 5.0 with 0.2 M phosphoric acid) in a ratio of 5:95. Phenomenex Luna 5-μm C18 (2)-150 x 4.6-mm, 5-μm) was used as the stationary phase. The column oven was set to a temperature of 30±1oC. Quantification was achieved with a DAD detector set at 210 nm. Resolution was achieved at a short run time of 3 minutes. With a flow rate of 1.0 mL per minute. Hydroxyurea eluted at 1.557±0.024 minutes. The method was found to be specific, robust, accurate and precise for the estimation of Hydroxyurea in fixed oral dosage tablets over the concentration ranges of 0.09 mg/mL - 1.064 mg/mL. The Correlation Coefficient (r2) was observed to be 0.9998. The LOD and LOQ were found to be 4.4x10-4 mg/mL and 1.33 x10-3 mg/mL respectively. The proposed method is precise, specific, accurate and robust for the estimation of Hydroxyurea in oral solid dosage from.