Title:Applicability of QbD-assisted Analytical Method for Simultaneous Detection
of Tetrahydrocurcumin and Folic Acid in Developed Nanostructured Lipid
Carriers
Volume: 20
Issue: 8
Author(s): Parina Kumari, Sarwar Beg, Kamalinder K. Singh*Vandita Kakkar*
Affiliation:
- School of Pharmacy and Biomedical Sciences, University of Central Lancashire, PR1 2HE, United Kingdom
- Biomedical Evidence-based Transdisciplinary Health Research Institute, University of Central Lancashire, Preston
PR1 2HE, United Kingdom
- Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 160014,
India
Keywords:
Diabetic foot ulcer, nanostructured lipidic carriers, box-behnken design, analytical quality by design (AQbD), validation, stability studies, risk assessment, method robustness, international council for harmonisation (ICH), precision.
Abstract:
Aims: Applicability of QbD-assisted analytical method for simultaneous detection of tetrahydrocurcumin
and folic acid in developed nanostructured lipid carriers.
Background: Diabetic foot ulcer (DFU) is a multifactorial disorder that involves chronic inflammation,
oxidative stress and neuropathy. Current treatment therapies involving the use of growth factors
and skin substitutes being costly, are out of reach for the majority of patients. The present research
explored the usefulness of a combination of tetrahydrocurcumin and folic acid-loaded nanostructured
lipidic carriers in DFU.
Objectives: To develop and validate a QbD-assisted method for simultaneous analysis of tetrahydrocurcumin
(THC) and folic acid (FA). Applicability of the above method to determine total drug content
(TDC) and entrapment efficiency (EE) of nanostructured lipid carriers (NLCs) loaded with THC and FA.
Methods: A high-performance liquid chromatographic (HPLC) method was developed, optimized
and validated using Box-Behnken design for improved method performance. Chromatographic separation
was conducted on a Supelco 250 x 4.6 mm (5 μm) column with optimized mobile phase composition
containing tetrahydrofuran: citric acid buffer pH 3.5 (50:50) at a flow rate of 0.4 mL.min-1
and diode array detection between 210 and 360 nm.
Results: The method developed in a concentration range of 1 to 100 μg.mL-1 was found to be linear
(R2 0.999, p≤0.001), accurate (99.10-101.70%) and precise with high recovery values in intra and
inter-day results. The system adaptability and robustness evaluation revealed that the percent recovery
ranged from 96.90 to 102.80%, and the percent relative standard deviation (%RSD) values were
less than 2%. Moreover, the method was further applied for the determination of TDC (86±6% and
96±8%) and drug EE (81±21% and 73±13%) for THC and FA, respectively.
Conclusion: The investigation indicated the applicability of the developed and validated method for
the estimation of THC and FA in the developed nanostructured lipidic carriers.