Development and Validation of an HPLC-UV Method for Determination of Sertraline Hydrochloride and Application to Study Dissolution of Tablets

Sertraline hydrochloride, an antidepressant drug, belongs to the selective serotonin reuptake inhibitors. An HPLC-UV method suitable for studying the drug dissolution from different dosage strengths (25-100 mg) was developed and validated according to the Food and Drug Administration agency (FDA) reviewer guidance on validation of chromatographic methods and the recommendations of International Conference of Harmonization (ICH). Chromatographic separation was performed on a Shimadzu-10AV system using a Hpersil GOLD C18 column (4.6 x 150 mm, 5 mu m) for the separation and a mobile phase consisting of methanol and phosphate buffer (0.2 mol/L, pH 7.40) mixture (80: 20 V/V). Results indicated that the method was selective, linear in the range 10-300 mu g/mL (R-2 > 0.9996), accurate (88.47-103.31) and precise (CV%: 1.35-4.7). Stock solutions and the prepared samples exhibited satisfactory stability at room temperature. The method was robust to small changes in composition, pH of the mobile phase, and in flow rate. It was applied successfully to study dissolution from 50 mg Zoloft (R) tablet (Pfizer).