Robust U-HPLC Method Development of Desonide and its Application to In Vitro Release Testing (IVRT) of Topical Cream Products

Abstract

Background: The study focuses on establishing In Vitro Release Testing (IVRT) parameters for Desonide cream, following the guidelines of the Topical Classification System (TCS), to assess the bioequivalence between the Reference Listed Drug (RLD) and test. Aim: This study aimed to develop a reliable IVRT method using Franz diffusion cells. An environmentally friendly U-HPLC method was created to analyze Desonide in the samples. objective: This includes assessing Linearity, robustness, precision, sensitivity, reproducibility, selectivity, specificity, and recovery. In the context of In-vitro Release Testing (IVRT), the concept of accuracy becomes irrelevant because there isn't a definitive "actual" release rate. This is due to the variability in API release rates for a specific semisolid formulation under different test conditions Objective: To evaluate the drug release in Desonide products in accordance with SUPAC guidance, quantify the drug concentration using an analytical method, as per bioanalytical method validation guidelines, and ensure that the results meet the acceptance criteria. Linearity was established from 0.50μg/mL to 40μg/mL with acceptable regression values. Precision was confirmed three times, with an average % RSD of below 15% for 3 sets of 6QC level sample preparations. Stability tests demonstrated Desonide stability in receptor fluid (LLOQ and ULOQ) for 72 hours at 2-8°C and 25°C. Autosampler stability at LQC and HQC levels was proven at 25°C for 72 hours. Additionally, the stock solution remained stable at both 25°C and 2-8°C for 72 hours. Methods: The study involved evaluating the dosing regimen, release medium, and membrane while optimizing the U-HPLC method based on three variables including column temperature, mobile phase composition, and flow rate. After experimentation, it was determined that Nylon membrane and 0.9% NaCl: Methanol release media (70:30 v/v) with 1000 mg dose were used to maximize the release profile of desonide. Results: The created explanatory strategy is precise, delicate, and exact for measuring Desonide, with satisfactory Limits of Location LOD and Lower Limits of Measurement LLOQ measured at 0.15 and 0.50 ng /mL, respectively. The Regression coefficient r2 was identified to be 0.9996. The degree of Desonide measurement lessening was considered palatable, basically since the recuperation was underneath 30.00, additionally due to the favourable linear relationship watched within the Desonide discharge rates amid the IVRT study. Conclusion: All three generic products analyzed were found to be equivalent to the RLD, meeting for "sameness" outlined in the FDA's SUPAC-SS guidance. A novel U-HPLC method was developed for Desonide, covering the range from 0.5 to 40 μg/ml, with intra and inter-day variability below 2% RSD. Additional characterizations were established, and the stability of Desonide was successfully determined.