Simultaneous Quantification RP-HPLC Method Development and Validation for Atorvastatin and Tadalafil in Bulk Form

Home > 2023, Vol. 11 No. 01 > Simultaneous Quantification RP-HPLC Method Development and Validation for Atorvastatin and Tadalafil in Bulk Form

Published: April 23, 2023

Download PDF

Download XML | Download HTML

Authors

Ifroj, Baljeet Kaur and Monika Gupta

DOI Number
https://doi.org/10.15415/jptrm.2023.111007

Keywords
Reverse Phase-HPLC, Atorvastatin, Tadalafil, Simultaneous estimation, Method validation

Abstract

Background: Tadalafil and Atorvastatin together have been shown to significantly enhance hemodynamics and sexual performance in middle-aged and older patients with hyperlipidemia. Despite of the number of techniques for estimating tadalafil and atorvastatin calcium, the Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) technique for simultaneous determination of Atorvastatin calcium and Tadalafil has not yet been disclosed.

Purpose: A sensitive, simple, rapid, reverse phase high pressure liquid chromatography (RP-HPLC) method has been developed and validated for the simultaneous estimation of Tadalafil and Atorvastatin in bulk form.

Methods: The method was carried out utilizing the C-18 column (Sapphirus, 5 x 250 mm) and mobile phase at 1 ml/min flow rate. 0.05M phosphate buffer (30:70 v/v gradient mode) and acetonitrile were the ideal mobile phase conditions. The pH was changed with glacial acetic acid to 4.0.

Results: Tadalafil and Atorvastatin had retention times of 3.517 and 4.117, respectively, according to data collected concurrently. The linearity range for Atorvastatin and Tadalafil (15 µg/ml to 90 µg/ml) was established using an external standard calibration method. It was calculated that the recovery rate ranges from 98.09 to 101.44 percent, and it was discovered that all values fall within this range. The limits of detection for Atorvastatin and Tadalafil are 0.318 µg/ml and 0.672 µg/ml, respectively.

Conclusion: The method was found to be robust, durable, accurate and linear for validated parameters. The % RSD observed for flow rate, wavelength, and analyst variation was found to be below 2, which was considered acceptable in the robustness investigation.

References

Bhagyasree T., Injeti N., Azhakesan A., & Rao U.M.V., (2014). A review on analytical method development and validation, Int. J. of Pharm. Res. & Anal., 8, 444-448. https://www.ijpra.com/File_Folder/444-448(ijpra).pdf
Chang, C., Lee, J., Lin, J., Hung, Y., Liu, R., Shau, W., & Sheu, W.H. (2013). Effects of statins on lipid profile of hyperlipidemic patients in Taiwan. Tzu-Chi Med. J., 25, 168-174. https://doi.org/10.1016/j.tcmj.2013.06.001
Du L., Jia J. H., Xue W. Y., Qi J. C. (2021). Effect of Tadalafil combined with Atorvastatin on hemodynamics and sexual function in middle-aged and elderly patients with hyperlipidemia complicated with erectile dysfunction. Pak. J. Med. Sci., 37(7), 1965-1971. doi: 10.12669/pjms.37.7.4257
Hatzimouratidis K. (2014). A review of the use of Tadalafil in the treatment of benign prostatic hyperplasia in men with and without erectile dysfunction. Ther. Adv. Urol. 6(4), 135-47. doi: 10.1177/1756287214531639
Henrie A. M., Nawarskas J. J., & Anderson J. R. (2015). Clinical utility of Tadalafil in the treatment of pulmonary arterial hypertension: an evidence-based review. Core Evid. 2(10), 99-109. doi: 10.2147/CE.S58457.
International Conference on Harmonization (ICH) Guidelines, (1996). Impurities in new drug products, IFPMA, Geneva.
Lal B., Kapoor D., & Jaimini M., (2019) A review on analytical method validation and its regulatory perspectives. J. drug delive. Ther., 9(2), https://doi.org/10.22270/jddt.v9i2.2403
Mónica F. Z., & De Nucci G. (2019). Tadalafil for the treatment of benign prostatic hyperplasia. Expert Opin. Pharmacother. 20(8), 929-937. doi: 10.1080/14656566.2019.1589452.
The United States Pharmacopeia, (2000), 24th Revision, Asian Edition, United States, Pharmacopeial Convention, Inc., Rockville, MD.
U.S. Food and Drug Administration Guidance for Industry, (2003). ICH Q3A, Impurities in New Drug Substances.

How to Cite

Ifroj, Baljeet Kaur and Monika Gupta. Simultaneous Quantification RP-HPLC Method Development and Validation for Atorvastatin and Tadalafil in Bulk Form. J. Pharm. Technol. Res. Manag.. 2023, 11, 71–76

Simultaneous Quantification RP-HPLC Method Development and Validation for Atorvastatin and Tadalafil in Bulk Form

Current Issue

Periodicity	Biannually
Issue-1	May
Issue-2	November
ISSN Print	2321-2217
ISSN Online	2321-2225
RNI No.	CHAENG/2013/50088

OA Policy

Publisher's policy of the journal at Sherpa UK for the submitted, accepted, and published articles. Click OAPolicy

Plan-S Compliance

To check compliance, one has to use the Journal Check Tool (JCT). This tool provided by cOAlition S (European funders) for the researchers (fundee) to check the compliance with the journal.

Recommend journal to your library

You can recommend the journal being a researcher or faculty member to your library. We will post a copy of the Journal to your library on your behalf at free of cost.
Click here: Recommend Journal

Preprint Arxiv Submission

The authors are encouraged to submit the author’s copy (preprint) to appropriate preprint archives e.g. https://arxiv.org and/or on https://indiarxiv.org or institutional repositories (e.g., D Space) before paper acceptance by the editor of Journal. After publications of the paper author(s) should mention the citation information, title and abstract along with DOI number of the publication carefully on the required page of the depository(ies).

Contact: Phone: +91-172-2741000, +91-172-4691800

Email : editor.jptrm@chitkara.edu.in;

Abstract and Indexing

Information

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

Articles in Journal of Pharmaceutical Technology, Research and Management (J. Pharm. Tech. Res. Management) by Chitkara University Publications are Open Access articles that are published with licensed under a Creative Commons Attribution- CC-BY 4.0 International License. Based on a work at https://jptrm.chitkara.edu.in/. This license permits one to use, remix, tweak and reproduction in any medium, even commercially provided one give credit for the original creation.

View Legal Code of the above-mentioned license, https://creativecommons.org/licenses/by/4.0/legalcode

View Licence Deed here https://creativecommons.org/licenses/by/4.0/