Determination of drotaverine hydrochloride in dosage forms

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Drotaverine hydrochloride DH 1 3 4 diethoxy benzylidene 6 7 diethoxy 1 2 3 4 tetrahydroisoquinoline is an antispasmodic drug widely used to relieve cramps or spasms of the stomach intestines and bladder Sweetman 2011 Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties It is a non anticholinergic antispasmodic which selectively inhibits


Yegorova et al Journal of Applied Pharmaceutical Science 3 05 2013 006 011 07. The lanthanide complexes are often used as a Measurement procedures of the luminescence spectrum of the. luminescence probes for inderect determination of some drugs Tb III R complex in presence of different concentration of DH. zidovudin Araujo et al 2002 catecholamines Takahashi et al 0 05 0 1 0 5 1 0 mL of DH working solution 100 g. 2002 enoxacin Karim et al 2007 omeprazole Shaghaghi et mL 1 and 0 2 0 3 0 5 0 6 0 7 0 8 0 9 1 0 1 5 2 0 3 0 4 0 mL. al 2008 ramipril Attia et al 2010 This work designed a of DH standard solution 1 mg mL 1 were placed into volumetric. novel platform for effective fluorimetric determination of DH in flasks 1 0 mL of a working terbium chloride solution 1 10 4 mol. pharmaceutical preparation based on luminescence quenching of L 1 0 1 mL of R working solution 1 10 3 mol L 1 and 0 4 mL of. terbium complex The suggested method is rapid simple sensitive urothropine buffer 40 were added to each of these volumetric. and can be used for the determination of DH in tablets flasks The solutions were diluted with water up to 10 mL and. stirred In 5 minutes the luminescence intensity is measured at. GENERAL EXPERIMENTAL ex em 317 545 nm, The determination of DH in pharmaceutical preparation No. All luminescence measurements luminescence spectra. excitation spectra and lifetimes are carried out on Cary Eclipse. Twenty tablets of an analyzed drug are weighed to, Varian Australia luminescence spectrophotometer in the range. calculate the average tablet weight and are then powdered and. 220 700 nm equipped with a 150 W xenon lamp 1 0 cm quarts. cell The excitation and emission monochromator band widths. The powder equivalent to 40 0 mg of the active, were 5 nm The excitation wavelength was set at 317 nm and the. ingredient are placed into a 200 mL volumetric flask mixed with. luminescence was measured using the peak height at 545 nm All. 50 mL of water stirred diluted with the same solvent up to 200. measurements were performed at room temperature 21 23 C A. mL and filtered to remove insoluble materials 5 mL of the filtrate. pH meter Lab 850 Schott Instruments GmbH Germany was. solution are placed into the 10 ml volumetric flask Further 1 0 mL. used for pH adjustment Absorption spectra are recorded with a. of a working terbium chloride solution 1 10 4 mol L 1. UV 2401 PC Shimadzu Japan spectrophotometer, 0 1 mL of R working solution 1 10 3 mol L 1 and 0 4 mL of. urothropine buffer were added to each of these volumetric flasks. Material and reagents, then water was added up to the volume of 10 mL and.
All of the used chemicals were of analytical grade or. luminescence intensity Ias are measured at ex em 317 545. chemically pure doubly distilled water was used Pharmaceutical. nm Ilum of standard solution Ist 1 0 mL of DH standard solution. preparation No spa tablets containing 40 mg of drotaverine. 1 mg mL 1 was placed into the volumetric flask then all. hydrochloride prodused by Chinoin Chemical Pharmaceutical. components with the exception of 5 mL of the filtrate solution. Sanofi Aventis Hungary are purchased from local market The. were added as described above was recorded at the same time. standard solution of terbium III chloride 1 10 1 mol L 1 was. Ilum of control solution I0 which contents all components with the. prepared from a high purity oxide The concentration of the metal. exception of DH was recorded at the same time I0 was considered. was determined by complexometric titration with Arsenazo I as. at calculation of Ilum of an investigated solution and standard. the indicator The ligand 1 bythyl 4 hydroxy 2 oxo 1 2 dihydro. quinoline 3 carboxylic acid 4 methyl pyridin 2 yl amide R. The content of DH X in one tablet in milligrams is calculated. was synthesized as described elsewhere Ukrainets et al 2004. using the formula, The standard solutions of reagent 1 10 3 mol L 1 was prepared by. dissolving accurate weights of the solid compounds in I1 m0 1 200 10 b I1 m0 0 8 b. dymethylformamide DMFA An accurately weighted 50 mg I 2 m1 50 10 5 I 2 m1. standard sample of drotaverine hydrochloride Akums Drugs. I1 the luminescence intensity of the assay I0 Ias, Pharmaceuticals Ltd Haridwar India was dissolved in water. I2 the luminescence intensity of standard I0 Ist, placed into a 50 mL volumetric flask stirred and diluted to the. I0 the luminescence intensity of control solution, mark with water and mixed well A standard solution of the. m0 the weight of standard mg, concentration 1 0 mg mL 1 was obtained The stock standard.
m1 the weight of powdered tablets mg, solution of DH was diluted to 100 g mL 1 before being used. b the average tablet weight mg, An urothropine buffer was prepared by dissolving 40 0 g. of urothropine in 100 mL volumetric flask with water. RESULTS AND DISCUSSIONS,General procedure Spectral characteristics. Preparation of lanthanide complex The absorption spectrum of R in DMFA water solution is. The complex of R with the Tb3 ion was prepared characterized by the presence of band with high molar absorption. by mixing the R at concentration of 1 10 4 mol L 1 and coefficient in the UV region of the spectra at max 313 nm. 1 10 4 mol L 1 in a molar ratio of 1 1 in water at room temperature 2 46 104 L mol 1 cm 1 is shown in Fig 1. 08 Yegorova et al Journal of Applied Pharmaceutical Science 3 05 2013 006 011. Fig 2 Excitation spectra of Tb III R complex a and luminescence spectra of. Tb III R in the presence of different concentration of DH b Conditions. Fig 1 The absorption spectrum of R Conditions R 5 10 5 mol L 1 in 50 Tb R 1 10 5 mol L 1 ex em 317 545 nm. The effect of different experimental conditions, This coefficient gives the possibility for effective Effect of pH. absorption of light energy The energy of triplet level T of R The complexation of Tb III with the ligand occurs in a. 22150 cm 1 is calculated from phosphorescence spectra of its Gd wide range of pH values from 3 to 10 The maximal luminescence. complex at 77 K This energy is higher than the energy of level of intensity of the complexes Tb III R is observed at pH 7 0 8 5. the first excited Tb3 ion state 5D4 20500 cm 1 resulting in The pH of solutions was maintained at 7 5 with urothropine buffer. the possibility of energy transfer from ligand R to lanthanide ion. Effect of stoichiometry, CH3 Applying the restricted logarithm method to the.
luminescence data it was found that in case of reagents shortage. or at equimolar ratio Tb forms complex compounds with R at the. N N component ratio Tb III R 1 1 850 s and if reagent is in. excess terbium forms complex compounds with R at the. component ratio Tb III R 1 3 1130 s The lifetime of. R the test complex is rather long The influence of ligand. concentration on the luminescence intensity was investigated at. The excitation spectra of the complex monitored at 545 constant Tb3 concentration of 10 0 mol The optimal conditions. nm shows an excitation maximum at 317 nm Fig 2 a It was were equal concentrations 10 0 mol of Tb3 and R which were. found that with the excitation wavelength at 317 nm the Tb III R chosen for further experiments. complex emitted the characteristic luminescence of Tb3 ion. with the emission peaks of 490 nm 545 nm 590 nm and The effect of the amount of DH. 620 nm which corresponded to 5D4 7F6 5D4 7F5 5D4 7F4 Fig 2 displays the spectral changes that occur when DH. and 5D4 7F3 transitions of Tb3 respectively Especially the is added to a solution of Tb III R The luminescence intensity of. 545 nm band is hypersensitive to changes of the coordination Tb III R complex was quenched and luminescence intensity of R. environment of the respective complex Therefore the was decreased in presence of various concentrations of DH The. changes of the luminescence intensity of this band are most interaction of the Tb R with DH causes a bathochromic shift of 30. often used for analytical applications with Tb III complexes nm in the luminescence maximum from 400 nm to 430 nm. Yegorova et al Journal of Applied Pharmaceutical Science 3 05 2013 006 011 09. Analytical performance When I0 I was modified by logarithm a linear relationship. The proposed method was validated in terms of linearity between the Log I0 I and concentration of DH was obtained. accuracy inter and intra day precision and specificity Table 1 Log I0 I 0 27 0 006 DH correlation coefficient is 0 9947. Fig 3 b The calibration curve is linear in the 0 5 300 0 g mL. Table 1 Summary of validation parameters range of DH The signal to noise ratio of 3 was considered as the. Parameter Results of DH limit of detection LOD The LOD for drotaverine hydrohloride. Linear range g mL 1 0 5 300 0,LOD g mL 1 0 16 was found to be 0 16 g mL 1. Correlation Coefficient r 0 9947 Accuracy of the analysis was evaluated by carrying out a. Accuracy n 6 99 86 recovery study at three different levels namely 80 100 and 120. Inter day n 10 2 4 The results of recovery study indicate that the proposed method is. Intra day n 10 3 1 accurate for estimation of drug in tablet dosage form Table 2. Specificity specific, Table 2 Recovery of DH in model solutions n 6 P 95. LOD Limit of detection g mL 1 Amount Amount Amount. Label claim Recovery RSD, The different concentrations of DH were added to added added found. Tb III R 1 1 complex The plot of Stern Volmer was obtained 31 80. 80 32 99 38 3 7, Fig 3 a I0 and I were measured at exc 317 nm and em 545 1 23. nm The plot of Stern Volmer was obtained I0 I 2 42 0 086 DH 40 20. 100 40 100 50 3 2,No spa 1 35, 0 0014 DH2 correlation coefficient is 0 9962 where I0 and I are 40 99 69.
the relative luminescence intensities of the system without and 120 48. 47 85 Average,1 41 recovery, with DH respectively CDH is concentration of drotaverine. hydrochloride g mL 1 As can be seen from Fig 3 a the Stern RSD Relative standard deviation. Volmer plot had been found to be non linear with an upward. curvature and obeyed the polynominal equation The precision of the method was established by testing the. analytical signal corresponding to a Drotaverine hydrohloride. concentration of 100 g mL 1 For a series of 10 measurements the. relative standard deviation was 2 4 for the intra days and 3 1. for the inter days analysis P 95 confidence level for DH. The specificity of the proposed method was investigated and no. interferences were observed between DH and some common. excipients for tablets formulations The interference of typical. excipients was studied by addition of the concentration of these. compounds to solution of 100 g mL 1 of DH As shown in the. Table 3 all excipients either had no effect or had little effect on. the determination of DH Hence specificity achieved by the. proposed method is good and it is possible to determine DH in the. presence of the excipients, Table 3 Tolerance limits of various interferents in the determination of 100. g mL 1 of DH,Interferent to,Interferents I,analyte ratio. Lactose anhydrous Granulac 200 50 1 3 0,Magnum stearate 0 7 1 3 5. Talk 1 3 1 2 1,Maize starch 7 1 3 1,Povidone K 17 13 1 2 2.
This method was used to assay the active ingredient Drotaverine. hydrochloride in dosage form tablets No spa 40 mg The. content of DH in dosage form in milligrams was calculated by the. standard sample method using the above formula Three batches of. DH tablets were analyzed The results are shown in Table 4 In. comparison with the spectrophotometry membrane selective. Fig 3 Non linear Stern Volmer plot a and modified linear Stern Volmer plot. electrodes and voltammetry methods reported as shown in Table. b for DH determination Conditions Tb R 110 5 mol L 1 ex em 317 545. nm 5 the proposed method in this paper offers higher sensitivity and a. 010 Yegorova et al Journal of Applied Pharmaceutical Science 3 05 2013 006 011. wider linear range In addition this method is more quick and testifies to the possible energy transfer between these components. simple than HPLC method The proposed luminescence method of the system Ilum quenching of R confirmes the intramolecular. for the determination of DH is simple reliable sensitive with the energy transfer from the reagent R curve 2 to the terbium ion in. advantage of a wide determination range that does not require the complex Tb III R curve 3. extraction Luminescence quenching of reagent curve 2 and luminescence. increase of DH curve 4 in comparison to I lum of free DH curve. Table 4 Determination of DH in tablets No spa 40 mg n 5 P 95 6 are observed because the energy transfer from the R to DH As. Batch Found mg RSD follows from curves 5 and 6 drotaverine does not form a complex. 0V097 39 85 1 24 2 5, 0V073 40 14 1 35 2 7 with the terbium ions There is quenching of intensity of. 0V092 39 97 1 49 3 0 luminescence of complex Tb III R curve 3 in the presence of. RSD Relative standard deviation DH can be explained by energy transfer from the reagent to DH. The results suggest that both static and dynamic quenching. Luminescence quenching mechanism, processes are responsible for the observed positive deviation in the. Luminescence quenching experiments were carried out. Stern Volmer plot, The drotaverine hydrochloride was used as a quencher in this. experiment Quenching mechanism DH on luminescence of. complex is combined static and dynamic The life time of the. terbium ion in the Tb III R complex 880 s decreases Fig. 4 in the presence of a various concentrations of DH 787 700. s that confirms the contribution of dynamic quenching. Fig 5 Excitation spectra of DH 1 and luminescence spectra 2 R 3. Tb III R 4 R DH 5 Tb III R DH 6 DH 7 Tb III DH Conditions. Tb R 1 10 5 mol L 1 DH 50 g mL 1 ex 317 nm,CONCLUSION. The new terbium complex with 1 bythyl 4 hydroxy 2, Fig 4 Luminescence decay curves of Tb III R complex without 1 and in oxo 1 2 dihydroquinoline 3 carboxylic acid 4 methyl pyridin 2.
presence 2 5 of DH Conditions DH 2 2 g mL 1 3 20 g mL 1 4. 50 g mL 1 5 100 g mL 1 Tb R 1 10 5 mol L 1 ex em 317 545 nm yl amide has high sensitivity and selectivity characteristic peaks. The intensities of these peaks are quenched by increasing the. Luminescence spectra of R Tb III R R DH Tb III R DH DH concentration of drotaverine hydrohloride On this basis a new. Tb III DH Fig 5 were studied for confirmation of interaction spectrofluorimetric method was developed for determination of. static mechanism in the system of Tb III R DH As can be seen DH The proposed method is simple accurate and easy to perform. from figure 5 there is overlapping of excitation spectrum of and can be used for the routine determination of DH in dosage. DH curve 1 with the luminescence spectrum of R curve 2 that forms. Table 5 Overview on selected assays for determination of Drotaverine hydrochloride. Linear range Limit of detection,Method Sample Reference. g mL 1 g mL 1, voltammetry 9 67 126 58 9 36 Pharmaceutical preparations Ziyatdinova et al 2007. liquid chromatography 0 2 100 0 05 Biological fluids Mezei et al 2006. liquid chromatography 0 032 0 96 0 011 Biological fluids Dahivelkar et al 2009. liquid chromatography 10 50 1 13 Pharmaceutical formulations Topagi et al 2010. spectrophotometry 2 10 Pharmaceutical preparations Metwally et al 2006. spectrophotometry 4 34 60 76 Pharmaceutical preparations Amin et al 2007. spectrophotometry 4 32 Pharmaceutical preparations Dahivelkar et al 2007. spectrophotometry 2 40 0 4 Pharmaceutical preparations Abdellatef et al 2007. spectrophotometry 10 50 Pharmaceutical preparations Rajmane et al 2009. spectrophotometry 2 40 0 4 Pharmaceutical preparations Metwally et al 2007. spectrophotometry 2 8 Pharmaceutical preparations Metwally et al 2008. membrane selective electrodes 4 34 4335 0 2 94 Tablets and biological fluids El Saharty et al 2006. membrane selective electrodes 0 867 4335 0 0 87 Pharmaceutical preparations Ibrahim et al 2005. spectrofluorimetry 0 16 4 0 032 Pharmaceutical preparation El Wasseef et al 2008. luminescence 0 5 300 0 0 16 Pharmaceutical preparation this work. 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