A Validated HPLC Method for the Determination of Rabeprazole in Bulk and Pharmaceutical Dosage form.
Journal Title: Journal of Biomedical and Pharmaceutical Research - Year 2013, Vol 2, Issue 1
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.
Authors and Affiliations
Muhammad Tariq Khalil*| Mohi Ud Din Islamic Institute of Pharmaceutical Sciences, Mirpur, AJ&K, Muhammad Usman| Mohi Ud Din Islamic Institute of Pharmaceutical Sciences, Mirpur, AJ&K, Sattar Bakhsh| Faculty of Pharmacy, Gomal University, D.I.Khan, Pakistan, Hafsa Bibi| Department of Chemistry, Gomal University, D.I.khan, Pakistan, Aisha Siddiqua| Department of Chemistry, Gomal University, D.I.khan, Pakistan, Rizwan Ali| Global pharmaceuticals (Pvt) Ltd. Islamabad
Keywords
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- EP ID EP1584
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