A Validated HPLC Method for the Determination of Rabeprazole in Bulk and Pharmaceutical Dosage form.

1Muhammad Tariq Khalil*, 1Muhammad Usman 2Sattar Bakhsh, 3Hafsa Bibi, 3Aisha Siddiqua, 4Rizwan Ali

1Muhammad Tariq Khalil*, 1Muhammad Usman 2Sattar Bakhsh, 3Hafsa Bibi, 3Aisha Siddiqua, 4Rizwan Ali 1. Mohi Ud Din Islamic Institute of Pharmaceutical Sciences, Mirpur, AJ&K 2. Faculty of Pharmacy, Gomal University, D.I.Khan, Pakistan 3. Department of Chemistry, Gomal University, D.I.khan, Pakistan 4. Global pharmaceuticals (Pvt) Ltd. Islamabad

Abstract

A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Rabeprazole in bulk and tablets dosage forms. The separation was achieved on C18 analytical column (250 mm × 4.6 mm i.d., 5.0 µm) using acetonitrile and phosphate buffer (pH 7) in the ratio 60:40 v/v as mobile phase and at a flow rate of 1.0 mL/min. Detection was carried out using a UV detector at 282nm. The total chromatographic analysis time per sample was about 10.0min with Rabeprazole eluting at retention time of about 13min. The method was validated for accuracy, precision, specificity, linearity and sensitivity. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 25-150µg/mL with R² close to one (1.0002). The limit of detection (LOD) and limit of Quantitation (LOQ) obtained for Rabeprazole were 0.02µg/mL and 0.05µg/mL, respectively. The developed and validated method was successfully applied for the quantitative analysis of Aptizole® Tablets. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of Rabeprazole in tablet dosage form.

KEY WORDS: Analytical method development, Reversed phase HPLC, ICH guidelines, Tablet dosage forms, Accuracy and precision