Title:Robust U-HPLC Method Development of Desonide and its Application to In Vitro Release Testing (IVRT) of Topical Cream Products
Volume: 20
Issue: 5
Author(s): Seelam Jayadev and Ismail Yusuff*
Affiliation:
- Crescent School of Pharmacy, B.S. Abdur Rahman Crescent Institute of Science and Technology, G.S.T. Road
Vandalur, Chennai-600048, Tamil Nadu, India
Keywords:
Desonide, ultra high-performance liquid chromatography (U-HPLC), vertical diffusion cell, food and drug administration, IVRT, united states pharmacopoeia, topical formulation, cream.
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.
Aims: 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.
Objectives: 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
0.50 μg/mL to 40 μg/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.
