Analytical Method Development and Validation for Simultaneous Estimation of Ilaprazole And Levosulpiride In Capsule

A simple, precise and accurate RP-HPLC method was developed for the separation and quantification of  Ilaprazole and Levosulpiride in pharmaceutical dosage form. The quantification was carried out using Hypersil BDS C8 column ( 150x 4.6mm,5µm) and mobile phase comprised of methanol and phosphate buffer(pH 7.5 adjusted with 0.01 M NaOH) in proportion of ratio 70:30 degassed under ultra- sonication. The flow rate was adjusted to 1 ml/min and the effluent was monitored at 242nm using PDA detector. The method was validated in terms of linearity, precision, accuracy and specificity, limit of detection and limit of quantization. Linearity of Ilaprazole and Levosulpiride were in range of 10-60 µg/ml and 75-450 µg/ml respectively. The retention time of Ilaprazole and Levosulpiride were 6.52 and 2.02 respectively. The percentage recoveries of both drugs were found to be 100.03%  and 100.18% for Ilaprazole and Levosulpiride respectively from the capsule formulation. The method was found to be precise, accurate and specific during the study. The proposed method enables rapid quantification and simultaneous analysis of both drugs from commercial formulations without any excipients interference. The method can be used for routine analysis of marketed product of Ilaprazole and Levosulpiride in combined capsule formulation.