RP-HPLC method validation for fast extraction and quantification of Levonorgestrel drug from silicone based intrauterine device intended for in-process and finished formulation

Background To develop and validate a simple and consistent reversed phase high performance liquid chromatography (RP-HPLC) method for the estimation of Levonorgestrel (LNG) drug from silicone based intrauterine device. Methods Sample solution was prepared using tetrahydrofuran (THF) as solvent for t...

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Bibliographic Details
Published in:Daru 2021-06, Vol.29 (1), p.185-193
Main Authors: Veeran, Midhu George, C., Karthikeyan, B., Bharaniraja, Painuly, Diksha, Aprem, Abi Santhosh
Format: Article
Language:English
Subjects:
Acetonitrile
Analysis
Biomedical and Life Sciences
Biomedicine
Chromatography, High Pressure Liquid - methods
Chromatography, Reverse-Phase - methods
Contraceptive Agents, Female - analysis
Contraceptive Agents, Female - chemistry
Contraceptive drug implants
Detectors
High performance liquid chromatography
Intrauterine Devices
IUD
Levonorgestrel
Levonorgestrel - analysis
Levonorgestrel - chemistry
Liquefied natural gas
Medicinal Chemistry
Methods
Pharmaceutical Sciences/Technology
Pharmacology/Toxicology
Reproducibility of Results
Research Article
Silicones
Silicones - chemistry
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Summary:Background To develop and validate a simple and consistent reversed phase high performance liquid chromatography (RP-HPLC) method for the estimation of Levonorgestrel (LNG) drug from silicone based intrauterine device. Methods Sample solution was prepared using tetrahydrofuran (THF) as solvent for the drug extraction, and RP-HPLC analysis was performed using Luna C18 analytical column (150 × 4.6 mm, 5 μm, 100 Å – Phenomenex), with a mobile phase consisting of a mixture of acetonitrile and water (50:50, v /v) at a flow rate of 1.0 ml/min and injection volume of 20 μl. Detection was carried out at 241 nm in PDA detector, with a total run time of 15 min. The method was validated in accordance with ICH guidelines. Method applicability was tested for optimizing formulation using quality-by-design approach, to check the stability and content uniformity of levonorgestrel-silicone mixture (core blend), and quantifying the amount of LNG from commercially available silicone based formulation. Results The retention time for LNG drug was obtained at 8.5 min (± 0.3 min). A linear relationship was observed over the concentration range of 2.6–15.6 μg/ml with the correlation coefficient (r) value 0.9999. The method was found to be precise within the acceptable limit (RSD 
ISSN:2008-2231
1560-8115
2008-2231
DOI:10.1007/s40199-021-00396-7