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 ADVANCED AMPLITUDE CENTERING AS AN INVIGORATING MANIPULATION FOR UNIFIED WAVELENGTH SPECTRAL RESOLUTION OF TERNARY MIXTURES

2017 ◽  
Vol 9 (5) ◽  
pp. 43 ◽  
Author(s):  
Hayam M. Lotfy ◽  
Sarah S. Saleh
Keyword(s):  
Standard Addition ◽  
Pharmaceutical Formulations ◽  
Partial Least Square ◽  
Least Square ◽  
Ternary Mixtures ◽  
The Novel ◽  
Validity Of Results ◽  
Accuracy And Precision ◽  
Significant Difference

Objective: This work presented the novel spectrophotometric approach namely, advanced amplitude centering (AAC). The method was applied for the resolution of ternary mixtures with partially or completely overlapped spectra.Methods: Advanced amplitude centering was based on the determination of ternary mixtures using single divisor where the concentrations of the components are determined through progressive manipulation performed on the same ratio spectrum. The centered amplitude at unified wavelength was resolved and applied for the determination of three components with partially and severely overlapped spectra. The work discussed the applications and advantages of the novel univariate advanced amplitude centering compared to the chemometric model, partial least square (PLS).Results: The specificity of the proposed methods was checked using laboratory-prepared mixtures of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCT) and was successfully applied for the analysis of two pharmaceutical formulations. The validity of results was assessed by applying the standard addition technique.Conclusion: The results obtained were found to agree statistically with those obtained by a reported method, showing no significant difference with respect to accuracy and precision.

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 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 Comparison of high-performance thin layer chromatography/UV-densitometry and UV-derivative spectrophotometry for the determination of trimetazidine in pharmaceutical formulations

2019 ◽  
Vol 69 (3) ◽  
pp. 413-422
Author(s):  
Marcin Gackowski ◽  
Marcin Koba ◽  
Katarzyna Mądra-Gackowska ◽  
Stefan Kruszewski
Keyword(s):  
Thin Layer ◽  
Thin Layer Chromatography ◽  
High Performance ◽  
Pharmaceutical Formulations ◽  
Linear Calibration ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Trimetazidine Dihydrochloride ◽  
Layer Chromatography

Abstract New methods for assaying trimetazidine dihydrochloride on the basis of thin layer chromatography and spectrophotometry are proposed and compared in the paper. In HPTLC/UV-densitometry, separation is achieved by using a mobile phase composed of ammonia-methanol (30:70, V/V) on silica gel HPTLC plates F254. Quantification using a non-linear calibration curve is accomplished by densito-metric detection at 230 nm. Derivative spectrophotometric determination of trimetazidine dihydrochloride is carried out from the fourth derivative of the absorbance at 233 nm in peak-zero mode. Statistical comparison led to the conclusion that there is no significant difference between the two studied methods and, moreover, that they demonstrate satisfactory accuracy and precision for routine applications.

Development of Validated UV Spectrophotometric Method for Assay of Ozagrel and its Pharmaceutical Formulations

2018 ◽  
pp. 69-77 ◽  
Author(s):  
Vishal N Kushare ◽  
Sachin S Kushare ◽  
Sagar V Ghotekar
Keyword(s):  
Spectrophotometric Method ◽  
Pharmaceutical Formulations ◽  
Routine Practice ◽  
Quantitation Limit ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Standard Values ◽  
Bulk Drug

UV Spectrophotometric method was developed and validated for the quantitative determination of Ozagrel in bulk drug and in pharmaceutical formulations. Ozagrel shows the maximum absorbance at 270 nm. Ozagrel follows Beer’s law in the concentration range of 1.0-10.0 µg/ml (r = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.4629 and 1.4027 µg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Ozagrel in assay of bulk drug and pharmaceutical formulations.

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.

Validated Stability-Indicating Spectrophotometric Methods for the Determination of Cefixime Trihydrate in the Presence of its Acid and Alkali Degradation Products

2015 ◽  
Vol 98 (1) ◽  
pp. 35-45 ◽  
Author(s):  
Nadia M Mostafa ◽  
Laila Abdel-Fattah ◽  
Soheir A Weshahy ◽  
Nagiba Y Hassan ◽  
Shereen A Boltia
Keyword(s):  
Degradation Product ◽  
Degradation Products ◽  
Pharmaceutical Formulations ◽  
Regression Equations ◽  
Acid Degradation ◽  
Spectrophotometric Methods ◽  
First Derivative ◽  
Accuracy And Precision ◽  
Significant Difference

Abstract Five simple, accurate, precise, and economical spectrophotometric methods have been developed for thedetermination of cefixime trihydrate (CFX) in the presence of its acid and alkali degradation products without prior separation. In the first method, secondderivative (2D) and first derivative (1D) spectrophotometry was applied to the absorption spectra of CFX and its acid (2D) or alkali (1D) degradation products by measuring the amplitude at 289 and 308 nm, respectively. The second method was a first derivative (1DD) ratio spectrophotometric method where the peak amplitudes were measured at 311 nm in presence of the acid degradation product, and 273 and 306 nm in presence of its alkali degradation product. The third method was ratio subtraction spectrophotometry where the drug is determined at 286 nm in laboratory-prepared mixtures of CFX and its acid or alkali degradation product. The fourth method was based on dualwavelength analysis; two wavelengths were selected at which the absorbances of one component were the same, so wavelengths 209 and 252 nm were used to determine CFX in presence of its acid degradation productand 310 and 321 nm in presence of its alkali degradation product. The fifth method was bivariate spectrophotometric calibration based on four linear regression equations obtained at the wavelengths 231 and 290 nm, and 231 and 285 nm for the binary mixture of CFX with either its acid or alkali degradation product, respectively. The developed methods were successfully applied to the analysis of CFX in laboratory-prepared mixtures and pharmaceutical formulations with good recoveries, and their validation was carried out following the International Conference on Harmonization guidelines. The results obtained were statistically compared with each other and showed no significant difference with respect to accuracy and precision.

Extractive Spectrophotometric Method for the Determination of Glibenclamide by Ion-Pair Complex in Pure Form and Pharmaceutical Formulation

2019 ◽  
Vol 9 (o3) ◽  
Author(s):  
RUAA MUAYAD MAHMOOD ◽  
HAMSA MUNAM YASSEN ◽  
SAMAR , NAJWA ISSAC ABDULLA AHMED DARWEESH ◽  
NAJWA ISSAC ABDULLA
Keyword(s):  
Spectrophotometric Method ◽  
Molar Absorptivity ◽  
Ion Pair ◽  
Pharmaceutical Formulation ◽  
Ratio Method ◽  
Colored Complex ◽  
Colored Product ◽  
Method Of Continuous Variation ◽  
Job's Method

Simple, rapid and sensitive extractive spectrophotometric method is presented for the determination of glibenclamide (Glb) based on the formation of ion-pair complex between the Glb and anionic dye, methyl orange (MO) at pH 4. The yellow colored complex formed was quantitatively extracted into dichloromethane and measured at 426 nm. The colored product obeyed Beer’s law in the concentration range of (0.5-40) μg.ml-1. The value of molar absorptivity obtained from Beer’s data was found to be 31122 L.mol-1.cm-1, Sandell’s sensitivity value was calculated to be 0.0159 μg.cm-2, while the limits of detection (LOD) and quantification (LOQ) were found to be 0.1086 and 0.3292 μg.ml-1, respectively. The stoichiometry of the complex created between the Glb and MO was 1:1 as determined via Job’s method of continuous variation and mole ratio method. The method was successfully applied for the analysis of pharmaceutical formulation.

scholarly journals Spectrophotometric determination of dothiepin hydrochloride in pharmaceuticals through ion-pair complexation reaction

2012 ◽  
Vol 18 (2) ◽  
pp. 339-347 ◽  
Author(s):  
Sameer Abdulrahman ◽  
Kanakapura Basavaiah
Keyword(s):  
Ion Pair ◽  
Pure Form ◽  
Bromocresol Green ◽  
Bromophenol Blue ◽  
Complexation Reaction ◽  
Conditional Stability ◽  
Conditional Stability Constant ◽  
Accuracy And Precision ◽  
Significant Difference

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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