UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF NORETHINDRONE IN IMMEDIATE RELEASE TABLET

Authors

  • Kailash Bansal Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India
  • Pankaj Pant Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India
  • Rama Therdana Rao P. Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India
  • Venkateswar Reddy M. Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India
  • Kumud Padhee Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India
  • Ajit Sathapathy Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India
  • Prithipal Singh Kochhar Formulation, Research and Development Department, Jagsonpal Pharmaceuticals Limited, Plot No. 14-16, 55-57, SIDCUL, Rudrapur, Uttarakhand, India

Abstract

A modification of the U.S.P. dissolution method for the quantitative determination of Norethindrone in solid oral tablet is proposed. This modification consists of the use of varying concentration of sodium lauryl sulfate in dissolution media (0.1 N Hydrochloric acid) and use of UV spectroscopy instead of HPLC for analysis of samples. The rate and extent of dissolution of Norethindrone was much greater when high concentration of sodium lauryl sulfate 1.0% w/v was used. Different dissolution trials were conducted on a pre-optimized formulation. The proposed method has been applied successfully for the analysis of the drug in the tablet dosage form. The percentage assay of Norethindrone in tablet was 99.95%. This method has the advantage of quicker turnaround time of sample analysis and less cost involved. It can serve as a surrogate for HPLC method for the routine use in quality control laboratories of pharmaceutical industry.

Keywords:

In-vitro dissolution, Norethindrone, sodium lauryl sulfate, UV spectrophotometry.

DOI

https://doi.org/10.25004/IJPSDR.2011.030211

References

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2. ICH Guidelines Q2B: Validation of Analytical Procedures: Methodology, Center for Drug Evaluation and Research (CDER), Rockville, MD, 1997: 1-10.
3. Wang Q, Higgins JP. Analytical Method for drug product dissolution. Dissolution Technol. 2006; 13: 6-13.
4. Dorantes A, Stavchansky S. Modification of the U.S.P. dissolution method for the analysis of norethindrone and ethinyl estradiol tablets. Journal of Pharmaceutical Sciences 1994; 83: 379-381.
5. United States Pharmacopeia, USP32-NF27, U.S. Pharmacopeial Convention: Rockville, MD, 2009, pp. 3105.

Published

01-04-2011
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How to Cite

“UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF NORETHINDRONE IN IMMEDIATE RELEASE TABLET”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 3, no. 2, Apr. 2011, pp. 127-9, https://doi.org/10.25004/IJPSDR.2011.030211.

Issue

Volume 3, Issue 2, 2011

Section

Research Article

Copyright (c) 2011 Kailash Bansal, Pankaj Pant, Rama Therdana Rao P., Venkateswar Reddy M., Kumud Padhee, Ajit Sathapathy, Prithipal Singh Kochhar

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite

“UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF NORETHINDRONE IN IMMEDIATE RELEASE TABLET”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 3, no. 2, Apr. 2011, pp. 127-9, https://doi.org/10.25004/IJPSDR.2011.030211.