Simultaneous spectrophotometric determination of finasteride and tadalafil in recently FDA approved Entadfi™ capsules

Abstract

Entadfi™ is a recently FDA approved pharmaceutical combination capsule of finasteride and tadalafil. It was prescribed for the treatment of urinary tract disorders caused by benign prostatic hyperplasia in men. This paper introduced the first spectrophotometric methods for simultaneous determination of finasteride and tadalafil in the pure form and in the pharmaceutical capsules. UV absorption spectra of finasteride and tadalafil exhibited overlap hindered the direct simultaneous determination of the cited drugs. The UV absorption spectra of finasteride and tadalafil were transformed to the second order derivative. Finasteride could be determined selectively at 230.80 nm without interference from tadalafil. Moreover, tadalafil could be determined selectively at 292 nm without interference from finasteride. The ratio spectra of the studied drugs were derived and the derived ratio spectra of each drug were transformed to the first order derivative. Finasteride could be determined selectively at 218.80 nm without interference from tadalafil. Moreover, tadalafil could be determined selectively at 289.60 nm without interference from finasteride. The methods showed linearity with an excellent correlation coefficient in the concentration range of 10–140 µg/mL for finasteride and 3–40 µg/mL for tadalafil. The methods were validated following ICH guidelines for accuracy, precision, robustness, limit of detection, limit of quantification, and selectivity. The methods were found to be sensitive with LOD values for finasteride and tadalafil of 2.406 µg/mL and 0.876 µg/mL using the second derivative with zero crossing method and 2.229 µg/mL and 0.815 µg/mL using the first derivative of ratio spectra method. The methods were successfully applied for the determination of the studied drugs in their laboratory prepared mixtures, with mean percent recovery for finasteride and tadalafil of 99.37% and 99.17% using the second derivative with zero crossing method and 99.74% and 99.56% using the first derivative of ratio spectra method. Furthermore, the described methods were successfully applied for determination of the studied drugs in Entadfi™ capsules without interference from excipients. Based on the proposed results, the described methods could be utilized as simple method for the quality control of the studied drugs.

Development of validated methods for the simultaneous quantification of Finasteride and Tadalafil in newly launched FDA-approved therapeutic combination: greenness assessment using AGP, analytical eco-scale, and GAPI tools

“…As shown in Table 3 , the results of the proposed methods were statistically compared with that of the reported one. 17 The values of t and F tests do not surpass the theoretical values, thus advocating that there is no significant variation between the developed methods in the proposed study and the reported one.…”

“…Table 5 shows a comprehensive greenness behavior difference between the proposed methods and that of the reported one 17 for the quantification of FIN and TAD. Regarding the eco-scale applied tool, the eco-scale scores of the three methods were above 75, revealing the excellent green analytical method of analysis.…”

“…In July 2022, a spectroscopic technique was developed for the determination of FIN and TAD in a capsule. 17 Literature data lack any chromatographic method for the assaying of the proposed combination in its dosage form.…”

Green adherent spectrophotometric determination of molnupiravir based on computational calculations; application to a recently FDA-approved pharmaceutical dosage form

“…Computational chemistry represents an integral approach, in HPLC [4] , [5] , spectrophotometry [6] , [7] and electrochemistry [8] , to the development of greener methods based on theoretical testing of compound interactions and reducing the use of toxic solvents [9] . Many analytical methods have been developed to demonstrate the quality of the drug materials including HPLC [10] , TLC [11] , specroflorimetry [12] , [13] , [14] , [15] , [16] , [17] as well as spectrophotometry [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] . Table 1.…”

Cytochrome P450 3A4‐mediated pharmacokinetic interaction study between tadalafil and canagliflozin using high‐performance thin‐layer chromatography

“…Thin layer chromatographic method and high-pressure liquid chromatographic methods were reported for the determination of TAD and CAN [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]. Spectrofluorimetric and spectrophotometric methods were reported for the determination of both drugs [24][25][26][27][28][29][30][31][32]. Quantitation of TAD by gas chromatography was reported [33,34].…”