Validation and Method Development of Tadalafil in Bulk and Tablet Dosage Form by RP-HPLC

Bojanapu, A.; Subramaniam, Ananda Thangadurai; Munusamy, Jambulingam; Dhanapal, K.; Jothimanivannan, C.; Sellappan, Malathi; Jayaprakash, Venkatesan

doi:10.1055/s-0034-1372608

Cited by 11 publications

(5 citation statements)

References 3 publications

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“…Reviewing the literature revealed that several methods have been described for determination of both TAD and VAR either in pharmaceutical preparations or in biological fluids. Regarding TAD, the following methods have been reported including: spectrophotometry , densitometry , high‐performance liquid chromatography (HPLC) , liquid chromatography‐tandem mass spectrometry (LC/MS/MS) , gas chromatography–mass spectrometry (GC‐MS) , using adsorptive stripping square wave voltammetry , and micellar electrokinetic capillary chromatography (MEKC) . Meanwhile, VAR was determined via different analytical procedures including: HPLC , LC/MS/MS , GC‐MS , electrochemical method , CE , and MEKC .…”

Section: Introductionmentioning

confidence: 99%

Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma

et al. 2015

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A valid, sensitive and rapid spectrofluorimetric method has been developed and validated for determination of both tadalafil (TAD) and vardenafil (VAR) either in their pure form, in their tablet dosage forms or spiked in human plasma. This method is based on measurement of the native fluorescence of both drugs in acetonitrile at λem 330 and 470 nm after excitation at 280 and 275 nm for tadalafil and vardenafil, respectively. Linear relationships were obtained over the concentration range 4-40 and 10-250 ng/mL with a minimum detection of 1 and 3 ng/mL for tadalafil and vardenafil, respectively. Various experimental parameters affecting the fluorescence intensity were carefully studied and optimized. The developed method was applied successfully for the determination of tadalafil and vardenafil in bulk drugs and tablet dosage forms. Moreover, the high sensitivity of the proposed method permitted their determination in spiked human plasma. The developed method was validated in terms of specificity, linearity, lower limit of quantification (LOQ), lower limit of detection (LOD), precision and accuracy. The mean recoveries of the analytes in pharmaceutical preparations were in agreement with those obtained from the comparison methods, as revealed by statistical analysis of the obtained results using Student's t-test and the variance ratio F-test.

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Section: Introductionmentioning

confidence: 99%

Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma

et al. 2015

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“…Tadalafil retention time was found to be 3.18 min. Tadalafil concentration was determined through a calibration curve of plotted peak area versus concentration [ 43 ].…”

Section: Methodsmentioning

confidence: 99%

Application of Box-Behnken Design in the Preparation, Optimization, and In-Vivo Pharmacokinetic Evaluation of Oral Tadalafil-Loaded Niosomal Film

et al. 2023

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Benign prostatic hyperplasia (BPH) affects about 90% of men whose ages are over 65. Tadalafil, a selective PDE-5 inhibitor, was approved by FDA for BPH, however, its poor aqueous solubility and bioavailability are considered major drawbacks. This work intended to develop and evaluate oral fast dissolving film containing tadalafil-loaded niosomes for those who cannot receive the oral dosage form. Niosomes were statistically optimized by Box-Behnken experimental design and loaded into a polymeric oral film. Niosomes were assessed for their vesicular size, uniformity, and zeta potential. The thickness, content uniformity, folding endurance, tensile strength, disintegration time, and surface morphology were evaluated for the prepared polymeric film. The optimized niosomes revealed high entrapment efficiency (99.78 ± 2.132%) and the film was smooth with good flexibility and convenient thickness (110 ± 10 µm). A fast release of tadalafil was achieved within 5 min significantly faster than the niosomes-free drug film. The in-vivo bioavailability in rats established that the optimized niosomal film enhanced tadalafil systemic absorption, with higher peak concentration (Cmax = 0.63 ± 0.03 µg/mL), shorter Tmax value (0.66-fold), and relative bioavailability of 118.4% compared to the marketed tablet. These results propose that the oral film of tadalafil-loaded niosomes is a suitable therapeutic application that can be passed with ease to geriatric patients who suffer from BPH.

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“…For determination of AFH, HPLC [15][16][17][18][19], spectrophotometric [20][21][22][23][24][25], spectrofluorometric [25][26][27][28] and voltammetric [29][30][31] procedures were revealed. For TDF determination, different HPLC [32][33][34], spectrofluorometric [35][36][37][38], spectrophotometric [35,[39][40][41][42] and voltammetric [43][44][45][46] methods were reported for its analytical quantitation.…”

Section: Introductionmentioning

confidence: 99%

A synchronous spectrofluorometric technique for simultaneous detection of alfuzosin and tadalafil: applied to tablets and spiked biological samples

et al. 2022

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A facile, accurate, eco-friendly and sensitive spectrofluorometric method was evolved to assay alfuzosin hydrochloride (AFH) and tadalafil (TDF) in different matrices. Such a co-administered combination is clinically used for the treatment of lower urinary tract symptoms. Both compounds are characterized by their native fluorescence spectra upon excitation at specific wavelengths. Their characteristic fluorescence spectra were used for sensitive assay of the studied analytes in tablets and human biological samples. The assay principle is based on first-order synchronous spectrofluorometric scan using Δ λ = 60 nm in which AFH peaks were recorded at 366 nm. Meanwhile, TDF measurements were recorded at 293 nm in the same scans without overlap with AFH spectra. Recent analytical chemistry trends were implemented to lessen occupational and environmental perils, using ethanol as a diluting solvent for method optimization and application. Linearity ranges were 5.0–90.0 and 10.0–100.0 ng ml −1 for AFH and TDF, respectively in their raw materials with average % recoveries of 100.44% and 99.73% in raw materials, 100.15% and 100.20% in spiked plasma, and 97.14% and 99.99% in spiked urine. The proposed method was successfully applied to Prostetrol and Starkoprex commercial tablets with no interference with common tablet additives.

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Validation and Method Development of Tadalafil in Bulk and Tablet Dosage Form by RP-HPLC

Cited by 11 publications

References 3 publications

Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma

Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma

Application of Box-Behnken Design in the Preparation, Optimization, and In-Vivo Pharmacokinetic Evaluation of Oral Tadalafil-Loaded Niosomal Film

A synchronous spectrofluorometric technique for simultaneous detection of alfuzosin and tadalafil: applied to tablets and spiked biological samples

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