A synchronous spectrofluorometric technique for simultaneous detection of alfuzosin and tadalafil: applied to tablets and spiked biological samples (original) (raw)
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Luminescence : the journal of biological and chemical luminescence, 2017
A highly sensitive, cheap, simple and accurate spectrofluorimetric method has been developed and validated for the determination of alfuzosin hydrochloride and terazosin hydrochloride in their pharmaceutical dosage forms and in human plasma. The developed method is based on the reaction of the primary amine moiety in the studied drugs with acetylacetone and formaldehyde according to the Hantzsch reaction, producing yellow fluorescent products that can be measured spectrofluorimetrically at 480 nm after excitation at 415 nm. Different experimental parameters affecting the development and stability of the reaction products were carefully studied and optimized. The fluorescence-concentration plots of alfuzosin and terazosin were rectilinear over a concentration range of 70-900 ng ml(-1) , with quantitation limits 27.1 and 32.2 ng ml(-1) for alfuzosin and terazosin, respectively. The proposed method was validated according to ICH guidelines and successfully applied to the analysis of th...
2015
The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of alfuzosin hydrochloride and finasteride in combined tablet dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra were obtained in methanol and the determinations were made at 258 nm for alfuzosin hydrochloride and 223 nm for finasteride. The linearity was obtained in the concentration range of 2-12 μg/ml for both alfuzosin hydrochloride and finasteride. The mean % recovery was 100.79 and 99.89 % for alfuzosin hydrochloride and finasteride respectively. The method was found to be simple, sensitive, accurate, precise and was applicable for the simultaneous determination of alfuzosin hydrochloride and finasteride in tablet dosage form.
Three accurate, simple and precise spectrophotometric methods for the determination of alfuzosin hydrochloride in bulk drugs and tablets are developed. The first method is based on the reaction of alfuzosin with ninhydrin reagent in N, N'-dimethylformamide medium (DMF) producing a colored product which absorbs maximally at 575 nm. Beer's law is obeyed in the concentration range12.5-62.5 µg/mL of alfuzosin. The second method is based on the reaction of drug with ascorbic acid in DMF medium resulting in the formation of a colored product, which absorbs maximally at 530 nm. Beer's law is obeyed in the concentration 10-50 µg/mL of alfuzosin. The third method is based on the reaction of alfuzosin with p-benzoquinone (PBQ) to form a colored product with λmax at 400 nm.The products of the reaction were stable for 2h at room temperature. The optimum experimental parameters for the reactions have been studied. The validity of the described procedures was assessed. Statistical analysis of the results has been carried out revealing high accuracy and good precision. The proposed methods could be used for the determination of alfuzosin in pharmaceutical formulations. The procedures were rapid, simple and suitable for quality control application.
International journal of biomedical science : IJBS, 2006
Bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) were used to determine alfuzosin hydrochloride either in pure form or in pharmaceutical formulations. Alfuzosin was extracted as an ion-pair complex from sample solution containing KCl-HCl buffer pH2.2, 2.4 and 2.6 into CHCl3 and the absorbance was measured at 407, 413 and 412nm with use of the cited reagents, respectively. The analytical parameters and their effects on the reported systems are investigated. The reactions were extremely rapid at room temperature and the absorbance values remains unchanged up to 24 h. Beer's law was obeyed in the concentration ranges 1.20-38.3, 0.85-46.0 and 0.63-34.0 μg/ml and detection limits were 0.28, 0.24 and 0.18 μg/ml with BCP, BPB and BTB, respectively. Recoveries were 98.80-101.33%. Interferences of the other ingredients and excipients were not observed. The proposed method is simple, fast and sensitive, and the first reported extractive method for the determinat...
Die Pharmazie, 2007
Validated stability-indicating spectrophotometric and spectrofluorimetric assays (SIAMs) were developed for the determination of alfuzosin hydrochloride (ALF) in the presence of its oxidative, acid, and alkaline degradation products. Three spectrophotometric methods were suggested for the determination of ALF in the presence of its oxidative degradation product; these included the use of zero order (0D), first order (1D), and third order (3D) spectra. The absorbance was measured at 330.8 nm for (0D) method, while the amplitude of first derivative (1D) method and that of third derivative (3D) method were measured at 354.0 and 241.2 nm, respectively. The linearity ranges were 1.0-40.0 microg/ml for (0D) and (1D) methods, and 1.0-10.0 microg/ml for (3D) method. Two spectrofluorimetric methods were developed, one for determination of ALF in the presence of its oxidative degradation product and the other for its determination in the presence of its acid or alkaline degradation products. ...
International Journal of Pharmacy and Pharmaceutical Sciences, 2016
Objective: A novel combination of Tadalafil (TAD) and Dapoxetine HCl (DAP) has been recently introduced into the market for the treatment of premature ejaculation. The aim of this work is the development and validation of simple, sensitive and accurate analytical methods for the determination of TAD and DAP in their binary mixture without prior separation. Methods: Synchronous fluorescence spectroscopic (SFS) methods coupled with continuous wavelet transforms (CWT) and Savitzky-Golay (SAVGOL) derivatization technique have been developed. Results: Under optimum conditions, TAD and DAP were determined in the concentration ranges of 0.01-3 µg/ml and 0.01-1.2 µg/ml, respectively. Conclusion: The developed methods have the requisite accuracy, selectivity, sensitivity and precision and were satisfactorily applied for the simultaneous determination of TAD and DAP in bulk powder and pharmaceutical preparations. The results obtained for the analysis of both drugs in their pure forms by the proposed methods were statistically compared to those obtained by applying a reported high performance liquid chromatographic method (HPLC) method. The statistical comparison showed that there is no significant difference between the proposed methods and the reported one with respect to accuracy and precision.
A simple and sensitive HPLC fluorescence method for determination of tadalafil in mouse plasma
Journal of Chromatography B, 2010
A simple and sensitive high-performance liquid chromatographic (HPLC) method utilizing fluorescence detection was developed for the determination of the phosphodiesterase type 5 inhibitor tadalafil in mouse plasma. This method utilizes a simple sample preparation (protein precipitation) with high recovery of tadalafil (∼98%), which eliminates the need for an internal standard. For constituent separation, the method utilized a monolithic C 18 column and a flow rate of 1.0 ml/min with a mobile phase gradient consisting of aqueous trifluoroacetic acid (0.1% TFA in deionized water pH 2.2, v/v) and acetonitrile. The method calibration was linear for tadalafil in mouse plasma from 100 to 2000 ng/mL (r > 0.999) with a detection limit of approximately 40 ng/ mL. Component fluorescence detection was achieved using an excitation wavelength of 275 nm with monitoring of the emission wavelength at 335 nm. The intra-and inter-day precision (relative standard deviation, RSD) values for tadalafil in mouse plasma were less than 14%, and the accuracy (percent error) was within -14% of the nominal concentration. The method was utilized on mouse plasma samples from research evaluating the potential cardioprotective effects of tadalafil on mouse heart tissue exposed to doxorubicin, a chemotherapeutic drug with reported cardiotoxic effects.
Microchimica Acta, 2005
A novel, quick, simple and highly sensitive spectrofluorimetric method was developed and validated for the determination of sitagliptin (SG) in its pharmaceutical formulations. The proposed method is based on investigation of the fluorescence spectral behavior of sitagliptin in an SDS micellar system. In an aqueous solution of phosphate buffer pH 4.0, the fluorescence intensity of SG in the presence of SDS was greatly enhanced, by 200%, i.e. twofold enhancement. The fluorescence intensity of SG was measured at 300 nm after excitation at 270 nm. The method showed good linearity in the range 0.03-10.0 mg/mL with a good correlation coefficient (r = 0.9998). The limits of detection and quantitation values were 5.31 and 16.1 ng/mL, respectively. The proposed method was successfully applied to the analysis of SG in its single and co-formulated commercial tablets; the results were in good agreement with those obtained using a reference method. Application of the proposed method was extended to stability studies of SG after exposure to different forced degradation conditions according to the ICH guidelines, such as acidic, alkaline, thermal, photo-and oxidative stress. The chemical structure of certain potential degradation products (DPs) were investigated using LC-MS. a The average of three separate determinations. M. M. Salim et al.
Chemistry Central Journal, 2011
A rapid, simple and sensitive synchronous specrtofluorimetric method has been developed for the simultaneous analysis of binary mixture of metoprolol (MTP) and felodipine (FDP). The method is based upon measurement of the synchronous fluorescence intensity of the two drugs at Δλ of 70 nm in aqueous solution. The different experimental parameters affecting the synchronous fluorescence intensities of the two drugs were carefully studied and optimized. The fluorescence intensity-concentration plots were rectilinear over the ranges of 0.5-10 μg/mL and 0.2-2 μg/mL for MTP and FDP, respectively. The limits of detection were 0.11 and 0.02 μg/mL and quantification limits were 0.32 and 0.06 μg/mL for MTP and FDP, respectively. The proposed method was successfully applied for the determination of the two compounds in their commercial tablets and the results obtained were favorably compared to those obtained with a comparison method.
International Journal of ChemTech Research
Two simple, accurate and precise spectrophotometric and potentiometric methods were developed for the determination of alfuzosin hydrochloride (ALF) and doxazosin mesylate (DOX) either in drug substances or in drug products. The spectrophotometric method is based on the extraction of drugs into chloroform as ion pairs with bromocresol green (BCG) or into dichloromethane with phenol red (PR). Under the optimum conditions, Beer's law was obeyed with good correlation coefficients (r= 0.9995-0.9997) in the concentration range 1-17 and 2-17 µg mL-1 ALF or 1-19 and 2-21 µg mL-1 DOX using BCG and PR, respectively. The potentiometric method involves the direct titration of ALF and DOX with N-bromosuccinimide (NBS) or N-bromophthalimide (NBP) in acidic medium and the end point is determined potentiometrically using platinum electrode. ALF and DOX can be determined quantitatively in the concentration range of 0.425-1.700 and 0.547-2.188 mg with recovery values of 99.68-99.92 and 99.97-100...