Simultaneous Quantification RP-HPLC Method Development and Validation for Atorvastatin and Tadalafil in Bulk Form
Authors
Ifroj, Baljeet Kaur and Monika Gupta
https://doi.org/10.15415/jptrm.2023.111007
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, 71–76Current Issue
| Periodicity | Biannually |
| Issue-1 | May |
| Issue-2 | November |
| ISSN Print | 2321-2217 |
| ISSN Online | 2321-2225 |
| RNI No. | CHAENG/2013/50088 |
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