Novel HPTLC densitometric methods for determination of tamsulosin HCl and tadalafil in their newly formulated dosage form: Comparative study and green profile assessment

Abstract

A promising combination of tamsulosin HCl and tadalafil has recently been introduced for treating two prevalent and associated urological disorders: benign prostate hyperplasia and erectile dysfunction. Novel HPTLC methods were designed and validated for assaying the cited drugs in their challenging combined formulation. Separation was achieved using HPTLC silica gel 60 F254 plates as a stationary phase with a densitometric measurement at 280 nm. The proposed methods with two different chromatographic systems were successfully applied: a conventional mixture (method I) of ethyl acetate–toluene–methanol–ammonia (5:3:2:0.5, by volume) and a greener one (method II) with ethyl acetate–ethanol–ammonia (8:2:0.1, by volume). The two methods were evaluated through a comparative study in terms of selectivity, tailing factor, developing time and concentration ranges. The greenness profile for each method was then appraised with several green guides, namely GlaxoSmithKline solvent sustainability guide, Environmental, Health and Safety (EHS) tool, National Environmental Method Index (NEMI) and Eco‐scale. Moreover, method specificity and peak homogeneity were evaluated by peak purity assessment using the winCATS® software spectral correlation tool. The methods have potential for being simple, fast, economic and selective, and the greener one could be a good option for sustainable analysis of the drugs.

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

“…Two correlation coefficients (r s,m and r m,e ) were then calculated by the aid of WinCATS ® spectral correlation tool and found to surpass the required limit (0.9990). Moreover, good correlation between standard and sample solutions for each drug was deduced from their superimposed UV spectra [49] (Figure S7, Supporting Information). For HPLC, the utilization of DAD allowed online recording the UV absorption spectra at multiple points across TMS and TAD peaks.…”

“…Several compositions of mobile phase were tried to reach the best resolution for TMS and TAD along with their studied degradation products. Trials were conducted by applying two different recently published mobile phases; a conventional mixture of ethyl acetate + toluene + methanol + ammonia (5:3:2:0.5, by volumes) and a greener one of ethyl acetate + ethanol + ammonia (8:2:0.1, by volumes) [49]. The greener mobile phase was firstly examined in an attempt to lessen environmental hazardous; however, tremendous spot tailing was observed for the two degradation products even after altering the solvents’ ratios.…”

“…This promising combination elevates treatment outcomes and patient compliance along with lower side effects [46,47]. TMS and TAD were quantified together by spectrophotometric [48] and HPTLC [49] methods. No stability-indicating method has been reported yet for their simultaneous determination.…”

Exploring an experimental combination of analytical quality by design and green analytical chemistry approaches for development of HPTLC densitometric protocol for the analysis of barnidipine hydrochloride

“…For each group, an index scale is given and calculated from zero to one. In this case, the higher the score is, the greater the potential hazard of the solvent must be; the lower the score is, the greener the solvent will be (Tantawy et al, 2020). Consequently, a EHS picture was constructed to assess the equivalence between acetonitrile and ethanol in the mobile phase.…”

Green & Sensitive pH-dependent Spectrofluorimetric Assay of Tamsulosin Hydrochloride and Tadalafil in their New Combined Formulation for Benign Prostatic Hyperplasia: Application to Spiked Human Plasma

“…TAM and TDL specifically together were analyzed in the recent literature by spectrophotometry [ 22 ], HPTLC [ 23 , 24 ] and HPLC [ 24 ]. The aim of this study was to utilize spectrofluorimetry as it is green, low cost and highly sensitive technique with low solvent consumption for TAM and TDL assay as a newly formulated binary mixture.…”