HPLC Method Development and Validation for the Estimation of Esomeprazole in Bulk and Pharmaceutical Dosage Form
A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of esomeprazole in bulk and tablet dosage forms. The separation was achieved on Thermo C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using acetonitrile and methanol in the ratio 50:50 v/v as mobile phase and at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 300nm. The total chromatographic analysis time per sample was about 8.0min with esomeprazole eluting at retention time of about 6.863±0.3 min. 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 5-25μg/ml with r2 close to one (0.999). The limit of detection (LOD) and limit of quantitation (LOQ) obtained for esomeprazole were 0.100μg/ml and 0.314μg/ml respectively. The developed and validated method was successfully applied for the quantitative analysis of ESOMZ 20 Tablet. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of esomeprazole in tablets dosage form.
Keywords: Analytical method development, Reversed phase HPLC method, ICH guidelines, Tablet dosage forms, Accuracy and precision
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).