scholarly journals Validated Spectrophotometric Methods for the Determination of Mycophenolate: An Anti-Neoplastic Agent in Bulk and Pharmaceutical Dosage Forms

2013 ◽  
Vol 2013 ◽  
pp. 1-4
Author(s):  
A. Narendra ◽  
D. Deepika ◽  
M. Mathrusri Annapurna
Keyword(s):  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods

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 Development and Validation of Spectrophotometric Methods for Determination of Fluoxetine, Sertraline, and Paroxetine in Pharmaceutical Dosage Forms

2005 ◽  
Vol 88 (1) ◽  
pp. 38-45 ◽  
Author(s):  
Ibrahim A Darwish
Keyword(s):  
Correlation Coefficients ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Factors Affecting ◽  
Spectrophotometric Methods ◽  
Linear Relationships ◽  
Relative Standard ◽  
Optimum Reaction ◽  
Standard Deviations

Abstract Three simple and sensitive spectrophotometric methods were developed and validated for determination of the hydrochloride salts of fluoxetine, sertraline, and paroxetine in their pharmaceutical dosage forms. These methods were based on the reaction of the N-alkylvinylamine formed from the interaction of the free secondary amino group in the investigated drugs and acetaldehyde with each of 3 haloquinones, i.e., chloranil, bromanil, and 2,3-dichloronaphthoquinone, to give colored vinylamino-substituted quinones. The colored products obtained with chloranil, bromanil, and 2,3-dichloronaphthoquinone exhibit absorption maxima at 665, 655, and 580 nm, respectively. The factors affecting the reactions were studied and optimized. Under the optimum reaction conditions, linear relationships with good correlation coefficients (0.9986–0.9999) were found between the absorbances and the concentrations of the investigated drugs in the range of 4–120 μg/mL. The limits of detection for the assays ranged from 1.19 to 2.98 μg/mL. The precision values of the methods were satisfactory; the relative standard deviations were 0.56–1.24%. The proposed methods were successfully applied to the determination of the 3 drugs in pure and pharmaceutical dosage forms with good accuracy; the recoveries ranged from 99.1 to 101.3% with standard deviations of 1.15–1.92%. The results compared favorably with those of reported methods.

scholarly journals Use of N, N-diethyl-p-phenylenediamine sulphate for the spectrophotometric determination of some phenolic and amine drugs

2010 ◽  
Vol 60 (2) ◽  
pp. 217-227 ◽  
Author(s):  
Padmarajaiah Nagaraja ◽  
Ashwinee Shrestha ◽  
Anantharaman Shivakumar ◽  
Avinash Gowda
Keyword(s):  
Spectrophotometric Determination ◽  
Correlation Coefficients ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Variable Parameters ◽  
Spectrophotometric Methods ◽  
Linear Relationships ◽  
Colored Product ◽  
And Performance

Use ofN, N-diethyl-p-phenylenediamine sulphate for the spectrophotometric determination of some phenolic and amine drugsSpectrophotometric methods are proposed for the determination of drugs containing a phenol group [salbutamol sulphate (SLB), ritodrine hydrochloride (RTD), isoxsuprine hydrochloride (IXP)] and drugs containing an aromatic amine group [dapsone hydrochloride (DAP), sulfamethoxazole (SFM), and sulfadiazine (SFD)] in pharmaceutical dosage forms. The methods are based on coupling ofN, N-diethyl-p-phenylenediamine sulphate with the drugs in the presence of KIO4to give a green colored product (λmaxat 670 nm) and a red colored product (λmaxat 550 nm), respectively. Linear relationships with good correlation coefficients (0.9986-0.9996) were found between absorbance and the corresponding concentration of drugs in the range 1-7, 2-22, 1-17, 1.5-12, 2-25, and 2-21 μg mL-1for SLB, RTD, IXP, DAP, SFM and SFD, respectively. Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. The RSD of intra-day and inter-day studies was in the range of 0.2-1.0 and 0.4-1.0%, respectively. No interference was observed from common pharmaceutical adjuvants. The reliability and performance of the proposed methods was validated statistically; the percentage recovery ranged from 99.5 ± 0.1 to 99.9 ± 0.3%. Limits of detection were 0.14, 0.21, 0.51, 0.44, 0.33 and 0.37 μg mL-1for SLB, RTD, IXP, DAP, SFM, and SFD, respectively.

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 Optimization of Two Flow-Injection Spectrophotometric Methods for the Determination of Indapamide in Pharmaceutical Dosage Forms

2005 ◽  
Vol 88 (4) ◽  
pp. 1148-1154 ◽  
Author(s):  
Juan C Rodríguez ◽  
Julia Barciela ◽  
Sagrario García ◽  
Carlos Herrero ◽  
Rosa M Peña
Keyword(s):  
Flow Injection ◽  
Screening Method ◽  
Pharmaceutical Preparations ◽  
Dosage Forms ◽  
Response Surfaces ◽  
Subsequent Formation ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision

Abstract Multivariate experimental design has been used to optimize 2 flow-injection spectrophotometric methods for the determination of indapamide in pharmaceutical dosage forms, both pure and commercial tablets. The methods are based on the oxidation of this drug with iron (III) in acidic medium and the subsequent formation of an intensive orange-red complex between the liberated iron (II) and 2,2′-bipyridyl or 1,10-phenanthroline reagents. Plackett-Burman designs were applied as a screening method to evaluate the most significant factors with few experiments. Central composite 23+ star designs were performed to evaluate the response surfaces. The methods have been fully validated and were applied successfully to the determination of indapamide in pure and pharmaceutical forms with good accuracy and precision. Therefore, the 2 proposed procedures are simple, inexpensive, and rapid flow methods for the routine determination of indapamide in pharmaceutical preparations.

Determination of pK a Values of Cefdinir and Cefixime by LC and Spectrophotometric Methods and Their Analysis in Pharmaceutical Dosage Forms

2011 ◽  
Vol 73 (11-12) ◽  
pp. 1171-1176 ◽  
Author(s):  
Nurullah Sanli ◽  
Senem Sanli ◽  
Umit Sızır ◽  
Mehmet Gumustas ◽  
Sibel A. Ozkan
Keyword(s):  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods

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.

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