Direct Spectrophotometric Determination of Perindopril Erbumine and Enalapril Maleate in Pure and Pharmaceutical Dosage Forms using Bromocresol Green

2021 ◽  
pp. 3276-3282
Author(s):  
Amir Alhaj Sakur ◽  
Bayan Balid
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Dosage Forms ◽  
Bromocresol Green ◽  
Pharmaceutical Dosage Forms ◽  
Enalapril Maleate ◽  
Spectrophotometric Methods ◽  
Perindopril Erbumine

In this article, it has been reported new, simple, sensitive and direct spectrophotometric methods for the determination of Perindopril Erbumine (PPE) and Enalapril Maleate (ENL) in pure and in pharmaceutical forms. Spectrophotometric methods are based on the formation of yellow colored ion-pair complexes between PPE, ENL and sulphonphthalein acid dye, Bromocresol green (BCG) into chloroform were measured at the wavelength of 414 and 415nm for PPE and ENL, respectively. The optimal analytical conditions were determined. The obtained complexes (BCG: PPE) and (BCG: ENL) reached maximum absorbance directly after formation at room temperature for a stability period of 24 h. Beer’s law were obeyed in the concentration ranges of (2-20)µg/mL for PPE and (8- 44)µg/mL for ENL, the limit of detection of 0.125μg/mL and 0.230μg/mL were found for PPE and ENL, respectively. The molar absorptivity coefficients were 4.4045*104 L.moL-1.cm-1 for PPE and 1,9330*104 L.moL-1.cm-1 for ENL. The stoichiometry of the complexes formed between PPE, ENL and BCG were 1:1. No interference was observed from common excipients occurred in pharmaceutical formulations and the proposed methods have been successfully applied to determine the PPE and ENL in some pharmaceutical products and in ENL combination dosage forms with hydrochlorothiazide (HCTZ). The proposed methods were successfully validated to be utilized in the quantitative analysis of PPE and ENL in their pure and pharmaceutical products. A good agreement between the developed spectrophotometric methods with the results obtained from official reference methods for the determination of the two drugs in some real samples demonstrate that the proposed methods were suitable to quantify PPE and ENL in pharmaceutical formulations.

scholarly journals Optimized and Validated Spectrophotometric Methods for the Determination of Enalapril Maleate in Commercial Dosage Forms

2008 ◽  
Vol 3 ◽  
pp. ACI.S643 ◽  
Author(s):  
Nafisur Rahman ◽  
Sk Manirul Haque
Keyword(s):  
Pharmaceutical Formulations ◽  
Acid Group ◽  
Dosage Forms ◽  
Complexation Reaction ◽  
Experimental Conditions ◽  
Chloranilic Acid ◽  
Pharmaceutical Dosage Forms ◽  
Enalapril Maleate ◽  
Spectrophotometric Methods

Four simple, rapid and sensitive spectrophotometric methods have been proposed for the determination of enalapril maleate in pharmaceutical formulations. The first method is based on the reaction of carboxylic acid group of enalapril maleate with a mixture of potassium iodate (KIO3) and iodide (KI) to form yellow colored product in aqueous medium at 25 ± 1°C. The reaction is followed spectrophotometrically by measuring the absorbance at 352 nm. The second, third and fourth methods are based on the charge transfer complexation reaction of the drug with p-chloranilic acid (pCA) in 1, 4-dioxan-methanol medium, 2, 3-dichloro 5, 6-dicyano 1, 4-benzoquinone (DDQ) in acetonitrile-1,4 dioxane medium and iodine in acetonitrile-dichloromethane medium. Under optimized experimental conditions, Beer's law is obeyed in the concentration ranges of 2.5-50, 20-560, 5-75 and 10-200 µg mL-1, respectively. All the methods have been applied to the determination of enalapril maleate in pharmaceutical dosage forms. Results of analysis are validated statistically.

scholarly journals DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FEBUXOSTAT FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTS IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (9) ◽  
pp. 115
Author(s):  
Jaspreet Kaur ◽  
Daljit Kaur ◽  
Sukhmeet Singh
Keyword(s):  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

Objective: A simple, accurate, and selective ultraviolet-spectrophotometric method has been developed for the estimation of febuxostat in the bulk and pharmaceutical dosage forms.Method: The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The developed method was validated statistically with respect to linearity, range, precision, accuracy, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and recovery. Specificity of the method was demonstrated by applying different stressed conditions to drug samples such as acid hydrolysis, alkaline hydrolysis, oxidative, photolytic, and thermal degradation.Results: The study was conducted using phosphate buffer pH 6.8 and λmax was found to be 312 nm. Standard plot having a concentration range of 1–10 μg/ml showed a good linear relationship with R2=0.999. The LOD and LOQ were found to be 0.118 μg/ml and 0.595 μg/ml, respectively. Recovery and percentage relative standard deviations were found to be 100.157±0.332% and <2%, respectively.Conclusion: Proposed method was successfully applicable to the pharmaceutical formulations containing febuxostat. Thus, the developed method is found to be simple, sensitive, accurate, precise, reproducible, and economical for the determination of febuxostat in pharmaceutical dosage forms.

scholarly journals New Spectrophotometric Methods for Estimation of Perindopril Erbumine in Bulk and Pharmaceutical Formulations

2014 ◽  
Vol 6 (2) ◽  
pp. 319-327
Author(s):  
A. Unnisa ◽  
K. V. G. Raju ◽  
K. Balaji ◽  
A. N. Jyothi ◽  
T. S. Kumar
Keyword(s):  
Regression Analysis ◽  
Citric Acid ◽  
Pharmaceutical Formulations ◽  
Bulk Sample ◽  
Molar Absorptivity ◽  
Dosage Forms ◽  
Spectrophotometric Methods ◽  
Perindopril Erbumine ◽  
Detection And Quantification

Three rapid, simple, inexpensive, precise, and accurate spectrophotometric procedures were developed for the determination of Perindopril erbumine (PPE) using cobalt-thiocyanate, citric acid and 2,3- dichloro-5,6-dicyano benzoquinone in bulk sample and in dosage forms. The procedures are based on the coordination complex of the drug (electron donor) and the chromogenic reagents used. The colored products are extracted into non aqueous solvents and measured spectrophotometrically at the optimum ?maxfor each complex. Regression analysis of Beer-Lambert plots showed good correlation in the concentration range of 30-70 µg mL?1, 4-20 µg mL?1 and 20-60 µg mL?1 for cobalt-thiocyanate, citric acid and 2,3- dichloro-5,6-dicyano benzoquinone, respectively. The apparent molar absorptivity, Sandell’s sensitivity, detection and quantification limits were calculated. The developed methods were successfully applied for the determination of PPE in bulk and pharmaceutical formulations without any interference from common excipients and hence can be used for their routine analysis. Keywords: Perindopril erbumine; Spectrophotometry; Cobalt-thiocyanate; Citricacid-acetic anhydride.  © 2014 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.   doi: http://dx.doi.org/10.3329/jsr.v6i2.16106 J. Sci. Res. 6 (2), 319-327 (2014)

scholarly journals DEVELOPMENT AND VALIDATION OF NEW SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ANTIPSYCHOTIC DRUG ASENAPINE MALEATE IN PURE AND DOSAGE FORMS

2020 ◽  
pp. 62-69
Author(s):  
RAGAA EL-SHEIKH ◽  
AHLAM E. ABD ELLATEIF ◽  
ESRAA AKMAL ◽  
AYMAN A. GOUDA
Keyword(s):  
Limit Of Detection ◽  
Dosage Forms ◽  
Ion Pair ◽  
Stoichiometric Ratio ◽  
Bromocresol Purple ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision ◽  
Significant Difference

Objective: Three sensitive, simple, precise, reproducible, and validated spectrophotometric methods have been developed for the determination of anti-psychotic drug (asenapine maleate) in pure and pharmaceutical dosage forms. Methods: The methods are based on the formation of yellow-colored ion-pair complex between asenapine maleate and three acid dyes, namely, bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) with absorption maxima at 410, 414 and 416 nm, respectively. Several parameters such as pH, buffer type and volume, reagent volume, the sequence of addition and effect of extracting solvent were optimized. Results: Under the optimum experimental conditions, beer’s law is obeyed over the concentration ranges of 1.0–20, 1.0–14, and 1.0-16 μg/ml for BCP, BPB and BTB, respectively, with good correlation coefficients (0.9994-0.9998). The apparent molar absorptivity and Sandell’s sensitivity values are reported for all methods. The limit of detection (LOD) and the limit of quantification (LOQ) values are found to be 0.27, 0.30, and 0.25 μg/ml and 0.90, 1.0, and 0.83 μg/ml for BCP, BPB and BTB, respectively. 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. Conclusion: The proposed methods were successfully applied for the determination of asenapine maleate in pharmaceutical formulations with good accuracy and precision. Statistical comparison of the results was performed using Student's t-test and variance ratio F-test at the 95% confidence level and there was no significant difference between the reported and proposed methods regarding accuracy and precision. Further, the validity of the proposed methods was confirmed by recovery studies via standard addition technique in accordance with ICH guidelines.

scholarly journals Determination of Fluoroquinolones in Pharmaceutical Formulations by Extractive Spectrophotometric Methods Using Ion-Pair Complex Formation with Bromothymol Blue

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Trung Dung Nguyen ◽  
Hoc Bau Le ◽  
Thi Oanh Dong ◽  
Tien Duc Pham
Keyword(s):  
Spectrophotometric Method ◽  
High Performance ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Bromothymol Blue ◽  
Pharmaceutical Products ◽  
Ion Pair ◽  
Spectrophotometric Methods ◽  
Method Of Continuous Variation

In this paper, we reported a new, simple, accurate, and precise extractive spectrophotometric method for the determination of fluoroquinolones (FQs) including ciprofloxacin (CFX), levofloxacin (LFX), and ofloxacin (OFX) in pharmaceutical formulations. The proposed method is based on the ion-pair formation complexes between FQs and an anionic dye, bromothymol blue (BTB), in acidic medium. The yellow-colored complexes which were extracted into chloroform were measured at the wavelengths of 420, 415, and 418 nm for CFX, LFX, and OFX, respectively. Some effective conditions such as pH, dye concentration, shaking time, and organic solvents were also systematically studied. Very good limit of detection (LOD) of 0.084 µg/mL, 0.101 µg/mL, and 0.105 µg/mL were found for CFX, LFX, and OFX, respectively. The stoichiometry of the complexes formed between FQs and BTB determined by Job’s method of continuous variation was 1 : 1. No interference was observed from common excipients occurred in pharmaceutical formulations. The proposed method has been successfully applied to determine the FQs in some pharmaceutical products. A good agreement between extractive spectrophotometric method with high-performance liquid chromatography mass spectrometry (HPLC-MS) for the determination of FQs in some real samples demonstrates that the proposed method is suitable to quantify FQs in pharmaceutical formulations.

scholarly journals Development and validation of spectrophotometric methods for determination of ceftazidime in pharmaceutical dosage forms

2008 ◽  
Vol 58 (3) ◽  
pp. 275-285 ◽  
Author(s):  
Basavaraj Hiremath ◽  
Bennikallu Mruthyunjayaswamy
Keyword(s):  
Pharmaceutical Formulations ◽  
Dosage Forms ◽  
Color Intensity ◽  
Reaction Conditions ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Colored Product ◽  
Ethylenediamine Dihydrochloride ◽  
Development And Validation

Development and validation of spectrophotometric methods for determination of ceftazidime in pharmaceutical dosage formsTwo spectrophotometric methods for the determination of ceftazidime (CFZM) in either pure form or in its pharmaceutical formulations are described. The first method is based on the reaction of 3-methylbenzothiazolin-2-one hydrazone (MBTH) with ceftazidime in the presence of ferric chloride in acidic medium. The resulting blue complex absorbs at λmax628 nm. The second method describes the reaction between the diazotized drug andN-(1-naphthyl)ethylenediamine dihydrochloride (NEDA) to yield a purple colored product with λmaxat 567 nm. The reaction conditions were optimized to obtain maximum color intensity. The absorbance was found to increase linearly with increasing the concentration of CFZM; the systems obeyed the Beer's law in the range 2-10 and 10-50 μg mL-1for MBTH and NEDA methods, resp.LOD, LOQand correlation coefficient values were 0.15, 0.79 and 0.50, 2.61. No interference was observed from common excipients present in pharmaceutical formulations. The proposed methods are simple, sensitive, accurate and suitable for quality control applications.

scholarly journals Uv Spectrophotometric Methods for Determination of Sofosbuvir in Pure Form and Pharmaceutical Dosage Forms in Presence of Its Alkaline Degradate

2020 ◽  
pp. 12-25
Author(s):  
Zeinab Adel Nasr ◽  
Noha S. Said ◽  
Sawsan A. Abdel-Razeq
Keyword(s):  
Good Accuracy ◽  
Dosage Forms ◽  
Difference Spectra ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Good Linearity ◽  
Ratio Difference ◽  
Accuracy And Precision ◽  
Tablet Dosage

Aims: Two spectrophotometric methods were developed and validated for the determination of sofosbuvir in presence of its alkaline degradate. Study Design: Ratio difference and ratio derivative methods were assisted for determination of sofosbuvir in presence of its alkaline degradate, laboratory-prepared mixtures and in tablet dosage forms. Place and Duration of Study: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al - Azhar University, between December 2019 and January 2020. Methodology: Two analytical methods were achieved and validated for the quantitative determination of Sofosbuvir in presence of its alkaline degradate. The first method was ratio difference (RD) method, where the UV absorption spectra of different concentrations of sofosbuvir were divided by the spectrum of a certain concentration (15 µg mL-1) as a devisor of its alkaline degradate to get the ratio difference spectra. Afterwards, the peak amplitudes difference between 253.7 and 243.5 nm were measured. The second method was the ratio derivative (1DR) method, where the first derivative of the ratio spectra (1DR) was obtained and its amplitude was measured at 247 and 268 nm. Good linearity was obtained over the concentration range of 3-15 µg mL-1 for the proposed methods. The proposed procedures were adopted for the selective determination of intact Sofosbuvir in presence of up to 80% of its degradation product. Sofosbuvir was exposed to different conditions as alkaline, acidic and oxidative degradation. Results: The proposed methods were developed and validated with good linearity range of 3-15 µg mL-1 for both methods, and also with good accuracy and precision. And the obtained results were statistically compared to those obtained by the reported method. Conclusion: Sofosbuvir was successfully determined by the proposed ratio difference and ratio derivative methods in bulk powder, laboratory prepared mixtures and tablet dosage form with good accuracy and precision. The methods were validated according to ICH guidelines. The results obtained were compared with those of the reported method and were found to be in good agreement.

scholarly journals Indirect spectrophotometric Indirect spectrophotometric determination of chlordiazepoxide in pharmaceutical formulations via oxidative coupling reaction with phenothiazine

2018 ◽  
pp. 7-14
Author(s):  
Hind Hadi ◽  
Mariam Jamal
Keyword(s):  
Oxidative Coupling ◽  
Coupling Reaction ◽  
Pharmaceutical Formulations ◽  
Molar Absorptivity ◽  
Dosage Forms ◽  
Calibration Plot ◽  
Pharmaceutical Dosage Forms ◽  
Oxidative Coupling Reaction ◽  
Formed Product

Abstract A sensitive, precise and reliable indirect spectrophotometric method for the determination of chlordiazepoxide (CDE) in pure and pharmaceutical dosage forms is described. The method is based on oxidative coupling reaction between amino group resulting from acidic decomposition of CDE with phenothiazine in the presence of sodium periodate to produce an intense green soluble dye that is stable and shows a maximum absorption at 602 nm. The calibration plot indicates that Beer’s law is obeyed over the concentration range of 0.1?50 µg/mL, with a molar absorptivity of 1×104 L/mol cm and correlation coefficient of 0.9994.All the conditions that affecting on the stability and sensitivity of the formed product were studied and optimized and the suggested method was effectively applied for the determination of CDE in commercial dosage forms.

scholarly journals Estimation of Levocetirizine in Bulk and Formulation by First Order Derivative Area under Curve UV-Spectrophotometric Methods.

2016 ◽  
Vol 2 (1) ◽  
pp. 09
Author(s):  
Pandurang Tukaram Mane
Keyword(s):  
Area Under Curve ◽  
Pharmaceutical Formulations ◽  
Order Derivative ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
First Order ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Significant Difference

Simple, fast and reliable spectrophotometric methods were developed for determination of Levocetirizine in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 235-243 nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Levocetirizine using 5-25?g/ml (r=0.9994) for first order Derivative Area under Curve spectrophotometric method. The proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Levocetirizine in pharmaceutical formulations.

scholarly journals Estimation of Tramadol Hydrochloride in Bulk and Formulation by Second Order Derivative Area Under Curve UV-Spectrophotometric Methods.

2015 ◽  
Vol 1 (7) ◽  
pp. 308
Author(s):  
Rekha Sudam Kharat
Keyword(s):  
Area Under Curve ◽  
Pharmaceutical Formulations ◽  
Second Order ◽  
Order Derivative ◽  
Tramadol Hydrochloride ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
Spectrophotometric Methods ◽  
Significant Difference

Simple, fast and reliable spectrophotometric methods were developed for determination of Tramadol Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 272-280nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Tramadol Hydrochloride using 2-10?g/ml (r=0.9925) for second order Derivative Area under Curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Tramadol Hydrochloride in pharmaceutical formulations.

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