An RP-HPLC method development and validation of organic impurities in isotretinoin

A strong oral drug that belongs to the retinoid family, isotretinoin (ISO) is mostly used to treat severe acne.
The goal of the current work was to provide analytical techniques, such as HPLC, for ISO estimation in soft
gel capsule forms. Its effectiveness in treating acne vulgarism is well-established, but because of its limited
therapeutic index and the possibility of side effects, its therapeutic usage has to be precisely quantified. Highperformance liquid chromatography has become a dependable method for measuring ISO quantitatively.
This study focuses on methods for sample preparation, chromatographic conditions, and detection strategies.
The influence of many chromatographic factors on the sensitivity, selectivity, and resolution of ISO peaks
is reviewed, including column type, mobile phase composition, and detection wavelength. The present study
which employs degassed n-hexane, ethyl acetate, and glacial acetic acid (970:30:0.1) selected as a mobile
phase, makes use of HPLC. To accomplish chromatographic separation, the Shimadzu HPLC system with a
PDA detector in 385 nm and silica (250 × 4.6 mm, 5 µm) was utilized. Injected at a flow rate of 0.1 ml/min
into the column. The drug solution had a 50 µl load volume and an 80 min run period. It was ambient
temperature (25oC) in the column. Additionally, to guarantee the dependability and repeatability of the
analytical procedure, validation characteristics such as specificity, linearity, accuracy, and precision are
clarified. The study also emphasizes how crucial it is to validate methods by ICH criteria to guarantee the
accuracy and dependability of analytical results. All things considered, this abstract offers a thorough
summary of the analytical techniques for measuring ISO.