scholarly journals Quality of Ceftriaxone Sodium in Lyophilized Powder for Injection Evaluated by Clean, Fast, and Efficient Spectrophotometric Method

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Patrícia Vidal de Aléssio ◽  
Ana Carolina Kogawa ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Uv Detector ◽  
Ceftriaxone Sodium ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Significant Difference ◽  
Gram Negative Organisms ◽  
Comparison Of The Results

Ceftriaxone sodium, an antimicrobial agent that plays an important role in clinical practice, is successfully used to treat infections caused by most Gram-positive and Gram-negative organisms. Since there are few rapid analytical methods for ceftriaxone analysis to use in the pharmaceutical routine, the aim of this research was to develop a new method able to quantify this cephalosporin. Therefore, a sensitive, rapid, simple UV spectrophotometric method for the determination and quantification of ceftriaxone sodium was proposed. The UV detector was set at 241 nm. Beer’s law obeyed the concentration range of 10–20 µg mL−1. Statistical comparison of the results with a well-established reported method showed excellent agreement and proved that there is no significant difference in the accuracy and precision. Intra- and interday variability for the method were less than 2% relative standard deviation. The proposed method was applied to the determination of the examined drugs in pharmaceutical formulations and the results demonstrated that the method is equally accurate, precise, and reproducible as the official methods.

scholarly journals A kinetic spectrophotometric method for the determination of lansoprazole in pharmaceutical formulations

2006 ◽  
Vol 71 (10) ◽  
pp. 1107-1120 ◽  
Author(s):  
Nafisur Rahman ◽  
Zehra Bano ◽  
Hejaz Azmi ◽  
Mohammad Kashif
Keyword(s):  
Spectrophotometric Method ◽  
Room Temperature ◽  
Pharmaceutical Formulations ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Kinetic Spectrophotometric ◽  
Comparison Of The Results ◽  
Calibration Equations ◽  
Method Show

Asimple kinetic spectrophotometric method has been developed for the determination of lansoprazole in pharmaceutical formulations. The method is based on the oxidation of the drug with alkaline potassium permanganate at room temperature. The reaction was followed spectrophotometrically by measuring the increase in the absorbance owing to the formation of MnO 42? at 610 nm (Method A) and the decrease in the absorbance at 530 nm due to the disapperance of MnO4? (Method B). Calibration procedures were adopted for the assay of the drug. The calibration curves were linear over the concentration ranges of 5-150 and 5-70?g ml-1, with the corresponding calibration Equations: rate = -3.915x10-6 + 5.271x10-5 c and ?A = 1.04x 10-3 + 1.78x10-3 c for methods A, and B, respectively. A statistical comparison of the results of the proposed procedures with those of the reference spectrophotometric method show excellent agreement and indicated no significant difference between the compared methods in terms of accuracy and precision. Interval hypothesis tests were also performed, which indicated that the true bias of all samples was less than ? 2 %. .

scholarly journals New Kinetic Spectrophotometric Method for Determination of Folic Acid in Pharmaceutical Formulations

2015 ◽  
Vol 50 ◽  
pp. 169-178
Author(s):  
Mouhammed Khateeb ◽  
Basheer Elias ◽  
Fatema Al Rahal
Keyword(s):  
Folic Acid ◽  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Fixed Time ◽  
Rate Data ◽  
Sulfuric Acid Medium ◽  
Significant Difference ◽  
Kinetic Spectrophotometric ◽  
Comparison Of The Results

A simple and sensitive kinetic spectrophotometric method has been developed for the determination of folic acid (FA) in bulk and pharmaceutical Formulations. The method is based on the oxidation of FA by Fe (III) in sulfuric acid medium. Fe (III) subsequently reduces to Fe (II) which is coupled with potassium ferricyanide to form Prussian blue. The reaction is followed spectrophotometrically by measuring the increase in absorbance at λmax 725 nm. The rate data and fixed time methods were adopted for constructing the calibration curves. The linearity range was found to be 1–20 μg mL-1 for each method. The correlation coefficient was 0.9978 and 0.9993, and LOD was found to be 0.91 and 0.09 μg mL-1 for rate data and fixed time methods, respectively. The proposed method has been successfully applied to the determination of FA in formulations with no interference from the excipients. Statical comparison of the results shows that there is no significant difference between the proposed and pharmacopoeial methods

scholarly journals Kinetic Spectrophotometric Determination of Certain Cephalosporins in Pharmaceutical Formulations

2009 ◽  
Vol 2009 ◽  
pp. 1-12 ◽  
Author(s):  
Mahmoud A. Omar ◽  
Osama H. Abdelmageed ◽  
Tamer Z. Attia
Keyword(s):  
Initial Rate ◽  
Pharmaceutical Formulations ◽  
Fixed Time ◽  
Rate Of Change ◽  
Ceftriaxone Sodium ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Cephalosporin Antibiotics ◽  
Kinetic Spectrophotometric

A simple, reliable, and sensitive kinetic spectrophotometric method was developed for determination of eight cephalosporin antibiotics, namely, Cefotaxime sodium, Cephapirin sodium, Cephradine dihydrate, Cephalexin monohydrate, Ceftazidime pentahydrate, Cefazoline sodium, Ceftriaxone sodium, and Cefuroxime sodium. The method depends on oxidation of each of studied drugs with alkaline potassium permanganate. The reaction is followed spectrophotometrically by measuring the rate of change of absorbance at 610 nm. The initial rate and fixed time (at 3 minutes) methods are utilized for construction of calibration graphs to determine the concentration of the studied drugs. The calibration graphs are linear in the concentration ranges 5–15 g  and 5–25 g  using the initial rate and fixed time methods, respectively. The results are validated statistically and checked through recovery studies. The method has been successfully applied for the determination of the studied cephalosporins in commercial dosage forms. Statistical comparisons of the results with the reference methods show the excellent agreement and indicate no significant difference in accuracy and precision.

scholarly journals Development and application of spectrophotometric method for quantitative determination of Metronidazole in pure and tablet formulations

2016 ◽  
Vol 2 (1) ◽  
pp. 28 ◽  
Author(s):  
Zeeshan Masood ◽  
Muhammad Tayyab Ansari ◽  
Sharjeel Adnan ◽  
Muhammad Asad ◽  
Muhammad Farooq ◽  
...  
Keyword(s):  
Quantitative Determination ◽  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Molar Absorptivity ◽  
Dosage Forms ◽  
Nitrite Ion ◽  
Colored Complex ◽  
Accuracy And Precision ◽  
Significant Difference

A rapid, simple and sensitive spectrophotometric method has been developed for the determination of metronidazole in pharmaceutical pure and dosage forms. The method depends on alkaline hydrolysis of metronidazole releases the nitro group as nitrite ion and yielded nitrite ions can be used to give a colored complex that absorbs maximally at 505 nm. Beer’s law is obeyed in the concentration ranges 9-100 mg/ml with molar absorptivity of 1.14 ×103 L mole-1 cm-1. The proposed method is precise, accurate and specific for the quantitative determination of drug in bulk and dosage forms. The results of analysis of commercial formulations and the recovery study of metronidazole suggested that there is no interference from any excipients, which are present in pharmaceutical formulations of metronidazole. Statistical comparison of the results was performed with regard to accuracy and precision using student’s t-test and F-ratio at 95% confidence level. There is no significant difference between the reported and proposed methods with regard to accuracy and precision.

scholarly journals Titrimetric and Spectrophotometric Assay of Oxcarbazepine in Pharmaceuticals Using N-Bromosuccinimide and Bromopyrogallol Red

2011 ◽  
Vol 2011 ◽  
pp. 1-8
Author(s):  
Nagaraju Rajendraprasad ◽  
Kanakapura Basavaiah ◽  
Kanakapura B. Vinay
Keyword(s):  
Spectrophotometric Method ◽  
Reference Method ◽  
Standard Addition ◽  
Molar Absorptivity ◽  
Spectrophotometric Methods ◽  
Bromopyrogallol Red ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Comparison Of The Results

Titrimetric and spectrophotometric methods are described for the determination of oxcarbazepine (OXC) in bulk drug and in tablets. The methods use N-bromosuccinimide (NBS) and bromopyrogallol red (BPR) as reagents. In titrimetry (method A), an acidified solution of OXC is titrated directly with NBS using methyl orange as indicator. Spectrophotometry (method B) involves the addition of known excess of NBS to an acidified solution of OXC followed by the determination of the unreacted NBS by reacting with BPR and measuring the absorbance of the unreacted dye at 460 nm. Titrimetry allows the determination of 6–18 mg of OXC and follows a reaction stoichiometry of 1 : 1 (OXC : NBS), whereas spectrophotometry is applicable over the concentration range of 0.8–8.0 μg mL-1. Method B with a calculated molar absorptivity of2.52×104 L mol-1 cm-1is the most sensitive spectrophotometric method ever developed for OXC. The optical characteristics such as limits of detection (LOD), quantification (LOQ), and Sandell's sensitivity values are also reported for the spectrophotometric method. The accuracy and precision of the methods were studied on intraday and interday basis. The methods described could usefully be applied to routine quality control of tablets containing OXC. No interference was observed from common pharmaceutical adjuvants. Statistical comparison of the results with a reference method shows an excellent agreement and indicates no significant difference in accuracy and precision. The reliability of the methods was further ascertained by recovery studies in standard addition procedure.

Comparative Study for the Assay of Plant Derived Chemicals in Pharmaceutical Formulation Using Methods Dependent on Factorized Spectra

2021 ◽  
Author(s):  
Nesma M Fahmy ◽  
Adel M Michael
Keyword(s):  
Pharmaceutical Formulations ◽  
Pharmaceutical Formulation ◽  
Ternary Mixtures ◽  
Ratio Method ◽  
The Novel ◽  
Naturally Occurring ◽  
Accuracy And Precision ◽  
Validation Parameters ◽  
Significant Difference

Abstract Background Modern built-in spectrophotometer software supporting mathematical processes provided a solution for increasing selectivity for multicomponent mixtures. Objective Simultaneous spectrophotometric determination of the three naturally occurring antioxidants—rutin(RUT), hesperidin(HES), and ascorbic acid(ASC)—in bulk forms and combined pharmaceutical formulation. Method This was achieved by factorized zero order method (FZM), factorized derivative method (FD1M), and factorized derivative ratio method (FDRM), coupled with spectrum subtraction(SS). Results Mathematical filtration techniques allowed each component to be obtained separately in either its zero, first, or derivative ratio form, allowing the resolution of spectra typical to the pure components present in Vitamin C Forte® tablets. The proposed methods were applied over a concentration range of 2–50, 2–30, and 10–100 µg/mL for RUT, HES, and ASC, respectively. Conclusions Recent methods for the analysis of binary mixtures, FZM and FD1M, were successfully applied for the analysis of ternary mixtures and compared to the novel FDRM. All were revealed to be specific and sensitive with successful application on pharmaceutical formulations. Validation parameters were evaluated in accordance with the International Conference on Harmonization guidelines. Statistical results were satisfactory, revealing no significant difference regarding accuracy and precision. Highlights Factorized methods enabled the resolution of spectra identical to those of pure drugs present in mixtures. Overlapped spectra of ternary mixtures could be resolved by spectrum subtraction coupled FDRM (SS-FDRM) or by successive application of FZM and FD1M.

scholarly journals Development and Validation of UV Spectrophotometric Method for the Determination of Cefuroxime Axetil in Bulk and Pharmaceutical Formulation

2013 ◽  
Vol 6 (1) ◽  
pp. 133-141 ◽  
Author(s):  
S. Binte Amir ◽  
M. A. Hossain ◽  
M. A. Mazid
Keyword(s):  
Spectrophotometric Method ◽  
Cost Effective ◽  
Cefuroxime Axetil ◽  
Pharmaceutical Formulation ◽  
Uv Spectrum ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Label Claim ◽  
Development And Validation

The present study was undertaken to develop and validate a simple, sensitive, accurate, precise and reproducible UV spectrophotometric method for cefuroxime axetil using methanol as solvent. In this method the simple UV spectrum of cefuroxime axetil in methanol was obtained which exhibits absorption maxima (?max) at 278 nm. The quantitative determination of the drug was carried out at 278 nm and Beer’s law was obeyed in the range of (0.80-3.60) µg/ml. The proposed method was applied to pharmaceutical formulation and percent amount of drug estimated (95.6% and 96%) was found in good agreement with the label claim. The developed method was successfully validated with respect to linearity, specificity, accuracy and precision. The method was shown linear in the mentioned concentrations having line equation y = 0.05x + 0.048 with correlation coefficient of 0.995. The recovery values for cefuroxime axetil ranged from 99.85-100.05. The relative standard deviation of six replicates of assay was less than 2%. The percent relative standard deviations of inter-day precision ranged between 1.45-1.92% and intra-day precision of cefuroxime axetil was 0.96-1.51%. Hence, proposed method was precise, accurate and cost effective.  Keywords: UV-Vis spectrophotometer; Method validation; Cefuroxime axetil; Recovery studies.  © 2013 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.   doi: http://dx.doi.org/10.3329/jsr.v6i1.14879 J. Sci. Res. 6 (1), 133-141 (2013)  

scholarly journals Stability indicating HPLC-Fluorescence detection method for the simultaneous determination of linagliptin and empagliflozin in their combined pharmaceutical preparation

2021 ◽  
Vol 12 (2) ◽  
pp. 168-178
Author(s):  
Mohamed Rizk ◽  
Ali Kamal Attia ◽  
Heba Yosry Mohamed ◽  
Mona Elshahed
Keyword(s):  
Fluorescence Detection ◽  
Mobile Phase ◽  
Pharmaceutical Preparation ◽  
Pharmaceutical Preparations ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Accuracy And Precision ◽  
Relative Standard ◽  
Significant Difference

A sensitive, accurate, and precise liquid chromatographic method has been developed and validated for the determination of Linagliptin (LNG) and Empagliflozin (EMP) in their combined tablets. Chromatographic separation was carried out on ODS-3 Inertsil® C18 column (150×4.6 mm, 5 µm). The mobile phase A (consisting of 0.30% Triethyl amine buffer (TEA) at pH = 4.5, adjusted using ortho-phosphoric acid); the mobile phase B (consisting of acetonitrile) was pumped through the column whose temperature was maintained at 40 °C, with a flow rate 1.7 mL/min, using gradient elution from 0-3 min A:B (75:25, v:v), then from 3-6 min the ratio changed to be A:B (60:40, v:v). Fluorescence detection (FLD) was performed at 410 nm after excitation at 239 nm. Acceptable linearity, accuracy and precision values of the proposed method were found over the concentration ranges of 0.5-15 µg/mL for LNG and 1.0-30 µg/mL for EMP with correlation coefficients of 0.9997 and 0.9998 in the case of LNG and EMP, respectively. The recoveries and relative standard deviations percentages were found in the following ranges: 98.56-101.85 and 0.53-1.52% for LNG and 98.00-101.95 and 0.31-1.05% for EMP. The detection and quantification limits were 0.15 and 0.45 µg/mL for LNG and 0.22 and 0.67 µg/mL for EMP. The optimized method was validated and proved to be specific, robust, accurate and reliable for the determination of the drugs in pure form or in their combined pharmaceutical preparations. No significant difference was found regarding accuracy and precision upon statistical comparison between the obtained results of the proposed method and those of the reported method. Furthermore, the proposed method is proved to be a stability-indicating assay after exposure of the studied drugs to variable forced degradation parameters, such as acidic, alkaline and oxidative conditions, according to the recommendations of the International Conference on Harmonization guidelines. The simplicity and selectivity of the proposed method allows its use in quality control laboratories.

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 Development of an Ultraviolet Spectrophotometric Method for the Determination of Ceftiofur Sodium Powder

2009 ◽  
Vol 92 (6) ◽  
pp. 1673-1680 ◽  
Author(s):  
marinês J E Souza ◽  
Natália Canedo ◽  
Paulo S Souza Filho ◽  
Ana M Bergold
Keyword(s):  
Spectrophotometric Method ◽  
Spectrophotometric Analysis ◽  
Uv Spectrophotometry ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Student’S T ◽  
Ceftiofur Sodium ◽  
Interday Precision ◽  
Student’S T Test

Abstract A UV spectrophotometric method was developed for determination of ceftiofur sodium in the drug substance and sterile powder for injection. The method validation, which yielded good results, included evaluation of the range, linearity, intraand interday precision, accuracy, recovery, specificity, robustness, LOQ, and LOD. The UV spectrophotometric determinations were performed at 292 nm. Good linearity was obtained between 2.5 and 20.0 g/mL. A prospective validation showed that the method is linear (r = 0.9999) and precise, with RSD values of 0.3 for product A and 0.4 for product B. The intraand interday precision values were &lt;2 for all samples analyzed. Comparison of UV spectrophotometry and LC by analysis of variance and Student's t-test showed no significant difference between methodologies. Moreover, the accuracy and precision obtained with the UV method correlated well with the values obtained with the LC method, and this correlation suggests that UV spectrophotometric analysis can be an inexpensive, reliable, and less time-consuming alternative to chromatographic analysis. The results demonstrated the validity of the proposed method as a simple and useful alternative for the determination of ceftiofur in routine QC analyses.

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