Open AccessANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION FOR DETERMINATION ASSAY AND CONTENT UNIFORMITY OF LEVONORGESTREL BY REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY
Author(s) -
Vikas kumar Pal,
Yogendra Pal
Publication year - 2020
Publication title -
asian journal of pharmaceutical and clinical research
Language(s) - English
Resource type - Journals
eISSN - 2455-3891
pISSN - 0974-2441
DOI - 10.22159/ajpcr.2020.v13i4.36771
Subject(s) - chromatography , levonorgestrel , high performance liquid chromatography , chemistry , dosage form , acetonitrile , population , medicine , research methodology , environmental health , family planning
Object: The main objective of the complete study is to develop a new method and also to validate the developed method for the determination of Assay and Content Uniformity of Levonorgestrel by reverse-phase high performance liquid chromatography (RP-HPLC).
Methods: RP-HPLC method was developed for simultaneous estimation of levonorgestrel using Hypersil ODS, 125 mm×4.6 mm×5 μm C8 column with a mixture of water, and acetonitrile solution with a ratio of 50:50 as a mobile phase at a flow rate of 1.3 mL/min with a detection of quantification wavelength of 242 nm. Method was selected after calculating system suitability and validated as per International Conference on Harmonization (ICH) guidelines.
Results: The developed analytical method parameters found within the limits as given in ICH and USP Guidelines and the total chromatographic analysis time per sample was 8 min with Levonorgestrel Eluting with retention time of 4.479, 4.479, and 4.467 min, respectively. The validated HPLC method was successfully applied for the determination of dissolution of levonorgestrel tablets.
Conclusion: The method is simple, precise, specific, and accurate. The newly developed method can be used for routine analysis of Levonorgestrel in tablet dosage form.