DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TADALAFIL IN BULK AND FORMULATION

  • SHRISHAIL M. GHURGHURE D. S. T. S. Mandal’s College of Pharmacy Solapur 413004. Maharashtra, India
  • MANISHA S. DYAWARKONDA D. S. T. S. Mandal’s College of Pharmacy Solapur 413004. Maharashtra, India
  • SACHIN YANJANE D. S. T. S. Mandal’s College of Pharmacy Solapur 413004. Maharashtra, India

Abstract

Objective: A new simple, sensitive, precise and reproducible spectroscopic method was developed for the determination of Tadalafil in Pharmaceutical formulation with Dimethyl Sulfoxide.


Methods: The UV spectrum of Tadalafil in Dimethyl sulfoxide (DMSO) showed λ max at 285.6 nm. Beer’s law is valid in the concentration range of 10-60µg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness.


Results: The method was demonstrated excellent linearity over the range of 10-60µg/ml with regression equation y= 0.0337x-0.1343 and regression correlation R2= 0.998. Moreover, the method was found to be highly sensitive with LOD (2.44µg/ml) and LOQ (7.40µg/ml).


Conclusion: Based on results, the proposed method can be successfully applied for assay of Tadalafil in various pharmaceutical dosage forms.

Keywords: Tadalafil, DMSO, UV-spectroscopic method

References

1. Natarajan R, Prabhu C, Rajendran NN. Formulation and evaluation of oral jelly containing tadalafil. Int J Res Pharm Chem 2014;4:479-83.
2. Mohammad Yunoos, D Gowri Shankar, B Pragathi Kumar. The determination of tadalafil in the bulk and pharmaceutical dosage form. E-J Chem 2010;7:833-6.
3. Zamirkhan, Amod SP, Atul AS. Estimation of tadalafil in bulk material and in pharmaceutical formulation by using derivative spectroscopy. Int J Spectrosc 2014. p. 1-6. https://doi.org/10.1155/2014/392421
4. https.//en.m.wikipedia.org. [Last accessed on 10 Dec 2019]
5. http.//www.accessdata.fda.gov. [Last accessed on 10 Dec 2019]
6. SC Sweetman. The complete drug reference, Pharmaceutical Press: London, UK; 2007.
7. PB Reddy, KA Reddy, MS Reddy. RP-HPLC method for validation and stability-indicating for the determination of tadalafil API in pharmaceutical formulations. Res Pharm Biotechnol 2010;2:1-6.
8. MR Shashikanth, D Yada. Validation of stability indicating methods and method development for assay of tadalafil by HPLC. Int J ChemTech Res 2010;2:329-33.
9. VP Rane, Patil KR, Shinde DB, N Sangshetti. Estimation of tadalafil in bulk drug and pharmaceutical dosage form by stability indicating LC method. Chem Anal 2009;54:679-89.
10. SA Patel, NJ Patel. HPTLC method for determination of tadalafil in pharmaceutical dosage form. Am J PharmaTech Res 2011;1:138-46.
11. D Vijaya Durga, K Himabindu, Kavitha A, D Anil Kumar. Forced degradation studies, quantification and in vitro dissolution studies of tadalafil by spectrofluorimetry. Asian J Pharm Clin Res 2013;6:326-9.
12. Validation of analytical procedures: text and methodology. ICH-Guidelines Q2 (RI); 2005.
13. Sisodiya Mayuri, S Ravindranath. Solubility enhancement, formulation development and evaluation of immediate-release tablet of antihypertensive drug tadalafil. J Drug Delivery Thera 2018;8:294-302.
14. Prakash M. Role of tadalafil in erectile dysfunction. INJRC 2009;20:250-2.
15. Mohammad Yasir Peerzade, Shakeel Memon, Kiran Bhise, Ansari Irfan Aamer. Development and validation of a uv-visible spectrophotometric method for estimation of ritonavir in bulk and formulation. Pharma Innovation J 2019;8:30-4.
16. Subhasis Dan, Magduma CS. Bioanalytical method development and validation of tadalafil with special emphasis on pharmacokinetic study in healthy Indian subjects for ODS formulation. Curr Anal Chem 2015;11:285-98.
17. PH Sonawane, Amit Khandekar, Chirag SR, Jawed Akhtar. Rapid estimation of tadalafil by reverse-phase high-performance liquid chromatography method in bulk and tablet formulation. Indian J Pharm Sci 2013;75:230-3.
18. Aboul Enein H, Ali I. Validated method for tadalafil analysis in pharmaceutical preparations by capillary electrophoresis. Chromatographia 2014;60:187-91.
19. Ahemad NA. Validated liquid chromatography-ultraviolet method for the quantitation of tadalafil in human plasma using liquid-liquid extraction. J Chromatography B 2007;852:403-8.
20. Anuj Modi Anurekha J, Vivek J, Shrivastava A. A validated UV spectrophotometric method for the determination of tadalafil in bulk and solid dosage form. JADR 2012;2:13-8.
21. Bhaskar Raju N, Mahaboob S, G Edukondalu. A novel RP-HPLC method for the quantification of tadalafil in formulations. Res Desk 2012;1:66-73.
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GHURGHURE, S. M., M. S. DYAWARKONDA, and S. YANJANE. “DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TADALAFIL IN BULK AND FORMULATION”. International Journal of Current Pharmaceutical Research, Vol. 12, no. 3, May 2020, pp. 74-77, doi:10.22159/ijcpr.2020v12i3.38310.
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