Cost Effective, Efficient and Stability indicating Method Development & Validation for determination of related substances for Levonorgestrel & Ethinyl Estradiol Tablets

  • Abhiram Dash Department of Science, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) – 466001
  • Neelu Jain Department of Science, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) – 466001
  • Harish Pandey School of Pharmacy, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) - 466001

Abstract

The objective of this research was to develop and validate a simple, specific and accurate reverse phase of high performance of liquid chromatographic method for the determination of levonorgestrel (LVG) and ethinylestradiol (EE) in tablets. The chromatographic system included column Sun Fire ODS (150 mm × 4.6 mm i.d., particle size at 5 μm), mobile phase consisting of acetonitrile: methanol: aquabidest (60:15:25) with the flow rate of 1 mL/minute and effluents monitored at 230 nm. The validation of RP HPLC method for the simultaneous determination of LVG and EE was determined by accuracy, precision, linearity, and limit of detection (LOD) as well as the limit of quantitation (LOQ) parameters. The linearity range of both drugs was 1-70 µg/mL and 2-14 µg/mL for LVG and EE, respectively. The recoveries of LVG and EE were at 101.78% and 102.44% with the coefficients of variation of 0.94% and 1.92%, successively. The LOD of LVG and EE value were of 0.84 µg/mL and 0.03 µg/mL, and LOQ value were of 2.79 and 0.09µg/mL, respectively.


Keywords: Levonorgestrel (LVG), Ethinylestradiol, Method Validation, Method Validation, HPLC

Keywords: Levonorgestrel (LVG), Ethinylestradiol, Method Validation, HPLC

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Author Biographies

Abhiram Dash, Department of Science, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) – 466001

Department of Science, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) – 466001

Neelu Jain, Department of Science, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) – 466001

Department of Science, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) – 466001

Harish Pandey, School of Pharmacy, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) - 466001

School of Pharmacy, Shri Satya Sai University of Technology and Medical Sciences, Sehore- (MP) - 466001

References

1. FDA Food and Drug Administration. Guidance for industry bioanalytical method validation. Rockville, MD, USA: Centre for Drug Evaluation and Research; 2013.
2. Shargel L, Wu-Pong S, Yu ABC. Applied biopharmaceutics and pharmacokinetics. 5th ed. New York: McGraw-Hill; 2004.
3. National Agency of Drug and Food Control. Regulation on bioequivalence testing of medicines, Jakarta, Indonesia. 2011.
4. Parasuraman S, Anish R, Balamurugan S, Muralidharan S, Kumar KJ, Vijayan V. An overview of liquid chromatography-mass spectroscopy instrumentation. Pharm Methods. 2014; 5:47–55.
5. European Medicines Agency. EMEA, guideline on bioanalytical method validation, sciences medicines health. London, UK: An Agency of the European Union; 2011.
6. Almeida AM, Castel-Branco MM, Falcao AC. Linear regression for calibration lines revisited: weighting schemes for bioanalytical methods. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 774:215–22.
7. Aboul Enein HY. Serignese V. Photodiode-Arrays Detection, in Encyclopaedia of Chromatography. 2002; 1-4. Marcel Deker. New York 28. Huber L. Validation and Qualification in Analytical Laboratories. Second Edition. 2007: 125-153. Informal Healthcare, USA, 29. Ermer J. Miller JH. Method Validation in Pharmaceutical Analysis, A Guide to Best Practice. 2005: 4-14. WILEY-VCH Verlag GmbH & Co.
8. Ghatol S, Vithlani V, Gurule S, Khuroo A, Monif T, Partani P. Liquid chromatography tandem mass spectrometry method for the estimation of lamotrigine in human plasma: application to a pharmacokinetic study. J Pharm Anal. 2013; 3:75–83.
9. Li W, Zhang J, Tse FLS. Handbook of LC-MS bioanalysis. Hoboken, New Jersey: John Wiley; 2013.
10. Van de Merbel N, Savoie N, Yadav M, Ohtsu Y, White J, Riccio M, et al. Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J. 2014; 16:392–9.
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Dash A, Jain N, Pandey H. Cost Effective, Efficient and Stability indicating Method Development & Validation for determination of related substances for Levonorgestrel & Ethinyl Estradiol Tablets. JDDT [Internet]. 15Mar.2021 [cited 20Apr.2021];11(2):153-6. Available from: http://jddtonline.info/index.php/jddt/article/view/4581