ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION FOR DETERMINATION ASSAY AND CONTENT UNIFORMITY OF LEVONORGESTREL BY REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY

  • Vikas kumar Pal Department of Pharmacy, Pranveer Singh Institute of Technology, Kanpur, Uttar Pradesh, India.
  • Yogendra Pal Department of Pharmacy, Pranveer Singh Institute of Technology, Kanpur, Uttar Pradesh, India.

Abstract

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.

Keywords: Method development, Method validation, Levonorgestrel, Reversed-phase high-performance liquid chromatography

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Pal, V. kumar, and Y. Pal. “ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION FOR DETERMINATION ASSAY AND CONTENT UNIFORMITY OF LEVONORGESTREL BY REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 4, Feb. 2020, pp. 101-7, doi:10.22159/ajpcr.2020.v13i4.36771.
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