scholarly journals Title DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF LEUKOTRIENE RECEPTOR ANTAGONIST MONTELUKAST SODIUM IN BULK AND PHARMACEUTICAL FORMULATIONS

Author(s):  
RAGAA EL SHEIKH ◽  
WAFAA S HASSAN ◽  
MARWA M EL-GABRY ◽  
AYMAN A GOUDA ◽  
SALEH S IDRIS ◽  
...  

Objective: Simple, sensitive, precise, reproducible, and validated visible spectrophotometric methods have been developed for the determination of leukotriene receptor antagonist drug, namely, montelukast (MNT) sodium in bulk and pharmaceutical preparations. Methods: Three spectrophotometric methods are based on the formation of yellow-colored ion-pair complexes between MNT sodium and three dyes, bromocresol green, bromophenol blue, and methyl orange with absorption maxima at 420, 416, and 426 nm, respectively. Results: The stoichiometric ratio of the formed ion-pair complexes was found to be 1:1 (drug:reagent) for all methods, as deduced by Job’s method of continuous variation. Several parameters such as pH, buffer type and volume, reagent volume, sequence of addition, and effect of extracting solvent were optimized to achieve high sensitivity, stability, low blank reading, and reproducible results. Under the optimum conditions, linear relationships with good correlation coefficients (0.9993–0.9999) were found over the concentration ranges of 1.0–10, 1.0–12, and 1.0–16 μg/mL with a limit of detection of 0.30, 0.29, and 0.27 μg/mL for bromocresol green, bromophenol blue, and methyl orange methods, respectively. Conclusion: The proposed methods were validated in accordance with ICH guidelines and successfully applied to the analysis of MNT sodium in pharmaceutical formulations. Statistical comparison of the results obtained by applying the proposed methods with those of the reference method revealed good agreement and proved that there was no significant difference in the accuracy and precision between the results. 

2014 ◽  
Vol 2014 ◽  
pp. 1-16 ◽  
Author(s):  
Ayman A. Gouda ◽  
Alaa S. Amin ◽  
Ragaa El-Sheikh ◽  
Amira G. Yousef

Simple, rapid, and extractive spectrophotometric methods were developed for the determination of some fluoroquinolones antibiotics: gemifloxacin mesylate (GMF), moxifloxacin hydrochloride (MXF), and enrofloxacin (ENF) in pure forms and pharmaceutical formulations. These methods are based on the formation of ion-pair complexes between the basic drugs and acid dyes, namely, bromocresol green (BCG), bromocresol purple (BCP), bromophenol blue (BPB), bromothymol blue (BTB), and methyl orange (MO) in acidic buffer solutions. The formed complexes were extracted with chloroform and measured at 420, 408, 416, 415, and 422 nm for BCG, BCP, BPB, BTB, and MO, respectively, for GMF; at 410, 415, 416, and 420 nm for BCP, BTB, BPB, and MO, respectively, for MXF; and at 419 and 414 nm for BCG and BTB, respectively, in case of ENF. The analytical parameters and their effects are investigated. Beer’s law was obeyed in the ranges 1.0–30, 1.0–20, and 2.0–24 μg mL−1for GMF, MXF, and ENF, respectively. The proposed methods have been applied successfully for the analysis of the studied drugs in pure forms and pharmaceutical formulations. Statistical comparison of the results with the reference methods showed excellent agreement and indicated no significant difference in accuracy and precision.


2015 ◽  
Vol 17 (1) ◽  
pp. 25-31
Author(s):  
Jasmin Shah ◽  
M Rasul Jan ◽  
Muhammad Tariq Shah

Simple, precise and sensitive extractive spectrophotometric methods have been developed for the determination of domperidone in pharmaceutical formulations. The new methods involve the formation of colored extractable ion pair complexes of the drug with bromothymol blue (BTB) and bromophenol blue (BPB) in acidic medium. The effects of various parameters like pH, reagent concentration and shaking time were studied. The extracted complexes of domperidone showed maximum absorbance at 410 nm with BTB and at 415 nm with BPB dye. The stiochiometry of the reaction between domperidone, BTB and BPB was found to be 1: 4. Domperidone was found to obey Beer’s law in the concentration ranges of 0.6-35 ?g/ml, 1-30 ?g/ml with BTB and BPB, respectively. The method has been applied successfully for the determination of domperidone in commercial tablets and suspension samples. The results obtained by the proposed methods were validated statistically and compared with the official HPLC method. DOI: http://dx.doi.org/10.3329/bpj.v17i1.22310 Bangladesh Pharmaceutical Journal 17(1): 25-31, 2014


2017 ◽  
Vol 16 (10) ◽  
pp. 2487-2500
Author(s):  
Ahmed Mohamed El Defrawy ◽  
Amr Lotfy Saber

Purpose: To develop a simple and cost effective spectrophotometric method for the determination of etilefrine hydrochloride (ET) in pharmaceutical formulations and human plasma.Methods: The method is based on extraction of ET into chloroform as ion-pair  complexes with bromocresol green (BCG) and methyl orange (MO) in acidic medium. The interaction of ET with BCG and MO reagents were investigated using  B3LYP/6-31G(d) level of theory. The geometrical parameters of the interacting species and the ion pairs formed were characterized based on their frontier  molecular orbitals, atomic charges, electrostatic potential map, as well as NBO analysis.Results: The colored species exhibited absorption maxima at 410 and 479 nm for the two systems in universal buffer of pH range (3.0 - 3.5), with molar absorptivity of 2.4 × 104 and 1.7 × 104 Lmol-1cm-1, for BCG and MO methods, respectively. The methods demonstrated good linearity with correlation coefficient ranging from  0.9987 – 0.9991 in the concentration ranges 0.5 – 16 and 2.0 – 18 μgmL-1 for BCG and MO methods, respectively. The composition ratio of the ion-association complexes was 1:1 in all cases as established by Job’s method. Sandell,s  sensitivity, correlation coefficient, detection and quantification limits were also calculated. Molecular descriptors were obtained based on optimized structures of the molecules under investigation, by applying the B3LYP/6-31G(d) method, and used to interpret the mode of interaction between these molecules to form the investigated ion pairs.Conclusion: The proposed methods make use of simple reagents, which a basic  analytical laboratory can afford. No interference was observed from common  pharmaceutical excipients and additives. ETMO ion pair has a larger interaction energy (higher stability) than ET-BCG ion pair as inferred from their interaction energies.Keywords: Density functional theory, Etilefrine hydrochloride, Ion pair complex, Spectrophotometry, Bromocresol green, Methyl orange, Geometric analysis


2006 ◽  
Vol 89 (4) ◽  
pp. 966-971 ◽  
Author(s):  
ArmaĞan Önal ◽  
Ş. Evrim Kepeki ◽  
S MÜge Çetin ◽  
Sidika ErtÜrk

Abstract Simple and reproducible spectrophotometric methods have been developed for determination of sertraline, fluoxetine, and venlafaxine in pharmaceutical preparations. The methods are based on the reactions between the studied drug substances and ion-pair agents (bromothymol blue, bromocresol green, or bromophenol blue) to produce yellow-colored ion-pair complexes in acidic buffers. After extracting in chloroform, the ion-pair complexes are spectrophotometrically determined at the optimum wavelength. Optimizations of the reaction conditions were carried out. Beer's law was obeyed within the concentration range from 1 to 15 μg/mL. The molar absorptivity, Sandell sensitivity, and detection and quantification limits were also determined. The developed methods were applied successfully for the determination of these drugs in some available commercial preparations. The results were compared statistically with those obtained from reported high-performance liquid chromatography methods.


2018 ◽  
Vol 35 (1) ◽  
pp. 55
Author(s):  
N. Rajendraprasad ◽  
K. Basavaiah ◽  
K. B. Vinay

Two new, simple, rapid and reproducible spectrophotometric methods have been developed for the determination of lamotrigine (LMT) both in pure form and in its tablets. The first method (method A) is based on the formation of a colored ion-pair complex (1:1 drug/dye) of LMT with bromocresol green (BCG) at pH 5.02±0.01 and extraction of the complex into dichloromethane followed by the measurement of the yellow ion-pair complex at 410 nm. In the second (method B), the drug-dye ion-pair complex was dissolved in ethanolic potassium hydroxide and the resulting base form of the dye was measured at 620 nm. Beer’s law was obeyed in the concentration range of 1.5-15 μg mL-1 and 0.5-5.0 μg mL-1 for method A and method B, respectively, and the  = corresponding molar absorptivity values are 1.6932 x 104 and 3.748 x 104L mol-1cm-1. The Sandell sensitivity values are 0.0151 and 0.0068 μg cm-2 for method A and method B, respectively. The stoichiometry of the ion-pair complex formed between the dug and dye (1:1) was determined by Job’s continuous variations method and the stability constant of the complex was also calculated. The proposed methods were applied successfully for the determination of drug in commercial tablets.


2012 ◽  
Vol 18 (2) ◽  
pp. 339-347 ◽  
Author(s):  
Sameer Abdulrahman ◽  
Kanakapura Basavaiah

Two simple, sensitive and extraction-free spectrophotometric methods are described for the determination of dothiepin hydrochloride (DOTH) both in pure form and in pharmaceutical tablets. The methods are based on ion-pair complex formation between dothiepin base (DOT) and two acidic dyes, namely, bromophenol blue (BPB) or bromocresol green (BCG) with absorption maximum at 425 nm for BPB method or 430 nm for BCG method. Beer?s law is obeyed over the concentration ranges of 1.0-15.0 and 1.0-17.5 ?g mL-1 DOT for BPB and BCG methods, respectively. The molar absorptivity values and Sandell?s sensitivity values are reported for both methods. The limits of detection (LOD) and quantification (LOQ) were calculated to be 0.18 and 0.53 ?g mL-1 for BPB method, and 0.17 and 0.50 ?g mL-1 for BCG method, respectively. The stoichiometry of the complex in either case was found to be 1: 1 and the conditional stability constant (KF) of the complexes has also been calculated. The proposed methods were applied successfully to the determination of DOTH in pure form and in its tablet form with good accuracy and precision. Statistical comparison of the results was performed using Student's t-test and variance ratio F-test at 95% confidence level and there was no significant difference between the official and proposed methods with regard to accuracy and precision. Further, the validity of the proposed methods was confirmed by recovery studies via standard addition technique.


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