Development and Validation of an In Vitro Dissolution Method Based on HPLC Analysis for L-Dopa Release From PLGA Nanoparticles
Journal Title: Bezmiâlem Science - Year 2021, Vol 9, Issue 1
Abstract
Objective: In the past decade, dissolution testing has emerged as a valauble tool for the characterization of drug product performance in the field of pharmaceuticals. During the development of new formulations, dissolutions tests assist in the evaulation of any changes in the formulation arising during manufacturing process, thereby assuring product quality and performance post manufacturing. Methods: In the present study, a simple high performance liquid chromatography (HPLC) method was developed and validated to quantitate the release of L‐Dopa from poly (D, L‐lactic‐co‐glycolic acid) (PLGA) nanoparticles. The chromatographic separation was performed with a reversed‐phase C18 column, using acetonitrilewater containing 0.05% trifluoroacetic acid (5:95, v/v) as a mobile phase at 280 nm. The developed method was validated for its specificty, linearity, accuracy, and precision according to the ICH guidelines. Results: The developed method was shown to be linear (r2 ≥ 0.995) in the concentration range of 125-40 μg/mL. The mean % recoveries were found to be 102.59-98.70%, indicating an agreement between the true value and the detected value. Solution stability was guaranteed by the addition of an antioxidant. The analytical method was shown to be suitable for the evaluation of release of L‐Dopa from PLGA nanoparticles. In vitro release of L‐Dopa was studied using sample and separate (SS) and dialysis membrane (DM) methods. To compare SS and DM methods, difference (ƒ1) and similarity (ƒ2) factors were calculated. No significant differences were recorded in the release kinetics of L‐Dopa from nanoparticles using both methods (ƒ1 <15 and ƒ2 >50). Conclusion: Dissolution test methods were compared and procedure for an analytical method based on HPLC was optimizated and validated for the dissolution of L‐Dopa loaded nanoparticles.
Authors and Affiliations
Sema ARISOY, Özgün SAYINER, Tansel ÇOMOĞLU
Keywords
Related Articles
- EP ID EP691823
- DOI 10.14235/bas.galenos.2020.3860
- Views 179
- Downloads 0
Comparison of Intravenous, Intra-articular, and Combined Tranexamic Acid Use in Primary Total Knee Arthroplasty without a Tourniquet and a Drain
Objective: We assessed the effect of tranexamic acid (TXA) route of administration on the estimated blood loss (EBL) in patients undergoing primary total knee arthroplasty (TKA) without tourniquet and drain use. Methods...
Adjuvant Chemotherapy in Elderly Patients with Early-stage Non-small Cell Lung Cancer
Objective: Early-stage non-small cell lung cancer (NSCLC) constitutes approximately 25-30% of newly diagnosed lung cancers. Elderly patients with NSCLC have generallly been underrepresented in clinical studies. We explor...
Inner Surface of Pterion in Terms of Surgical Approaches: An Anatomical Cadaveric Study
Objective: Aim of this study was to evaluate the morphometric features and the inner surface of the pterion in terms of surgical procedures for neighboring anatomical structures. Methods: Thirty five skeletally mature c...
Evaluation of Nosocomial Infections and Antimicrobial Resistance Profiles in the Intensive Care Units: Nine Years Experience
Objective: The aim of this study is to identify nosocomial infections and causative mikroorganisms in adult intensive care units of hospital and also to investigate the changes in antimicrobial resistance profiles over a...
Validation and Reliability of the Turkish Premenstrual Coping Measure
Objective: The aim of this study is to evaluate the Turkish validity and reliability of the premenstrual coping measure (PCM) among university students. Methods: The universe of this methodological study consisted of 36...