ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR TRETINOIN ESTIMATION

A straightforward, sensitive, and verified (RP-HPLC) technique was created to estimate the amount of retinoin in topical formulations. A Cosmosil C18 column with a mobile phase made up of methanol and water at a 90:05 (v by v) ratio is used to accomplish chromatographic separation. Detection is conducted at 356 nanometers, and the flow rate is retained constant in 1.0 mL/min. The correlation coefficient (R2) was nearly 1, and the method showed excellent linearity in the concentration range 5–25 µg/mL. High sensitivity is indicated by the determined limits of detection and quantification, which are 0.0443 µg/mL and 0.1343 µg/mL. The accuracy, precision, robustness, and specificity of the method were validated by ICH. For both intra-day, inter-day precision, the percentage RSD was continuously less than 2%, but Recovery studies showed that the accuracy was within reasonable bounds. Forced degradation studies are used to assess the stability of retinoin under various stress conditions, including acidic, basic, oxidative, thermal, and photolytic environments. Tretinoin's sensitivity to light, oxidative, and acidic environments was discovered, underscoring the necessity of appropriate formulation and storage techniques. For the routine analysis of Tretinoin in topical formulations, the developed RP-HPLC method is strong, dependable, and appropriate, guaranteeing quality control, stability evaluation, and adherence to regulatory requirements.