Stability-Indicating RP-HPLC Method Validation for Acitretin and its Related Substances in Capsules

A simple, specific, and precise high performance liquid chromatography method was developed and validated for the estimation of Acitretin in capsule dosage forms. Although the analytical method developed in-house, was based on monograph of Acitretin on British pharmacopoeia 2007, but it was modified to get better separation among Acitretin and its related substances. A Peerless Basic C₁₈ (CHROMATOPAK, 250 × 4.6 mm, 5μm), in isocratic mode, with mobile phase containing Ethanol: Water: Glacial Acetic acid (7:2.97:0.03 v/v) was used. The flow rate was 1.0 ml/min and effluent was monitored at 360 nm. The retention time of Acitretin was 19.4 min. The validation study is carried out fulfilling the ICH guidelines in order to prove the fundamental criteria for validation: specificity, linearity, precision, accuracy, robustness and solution stability. Proposed method was successfully applied for the quantitative determination of Acitretin in capsule dosage form.