Volume :

3

Issue :

2

Abstract :

Isotretinoin is a topical keratolytic agent which is used in the treatment of skin diseases including acne vulgaris. This paper deals with a simple, feasible and sensitive reverse-phase high-performance liquid chromatographic method for the quantitative determination of isotretinoin in pharmaceutical capsule dosage form. The chromatography was carried out by using HPLC system (Shimadzu LC2010HT) with UV- Visible dual absorbance detector (PDA), C18, 25 cm X 4.6 mm, 5 µm. The mobile phase consisting of 0.3% glacial acetic acid and water in the ratio of 85:15 and tetrahydrofuran and methanol used a diluent in the ratio of 20:80. The detection was made at 355 nm and the mobile phase flowed at 1 ml/min. Validation parameters included system suitability, specificity, linearity, accuracy precision (repeatability & reproducibility), robustness, ruggedness and stability were determined according to the ICH guidelines. The retention time of isotretinoin was found to be 12.33 min. Hence, the method could be successfully applied for routine analysis of isotretinoin in pharmaceutical dosage forms.