Eco-friendly spectrophotometric methods for assessment of alfuzosin and solifenacin in their new pharmaceutical formulation; Green profile evaluation via eco-scale and GAPI tools

2020 ◽  
Vol 16 ◽  
Author(s):  
Mamdouh R. Rezk ◽  
Mina Wadie ◽  
Soheir A. Weshahy ◽  
Mahmoud A. Tantawy
Keyword(s):  
Minor Component ◽  
Time Saving ◽  
Prostate Hyperplasia ◽  
Spectrophotometric Methods ◽  
Ratio Difference ◽  
Ich Guidelines ◽  
Mean Centering ◽  
Benign Prostate ◽  
Urological Diseases

Background: Alfuzosin is recently co-formulated with solifenacin for relieving two coincident urological diseases, namely; benign prostate hyperplasia and overactive bladder Objective: Herein, green, simple and rapid spectrophotometric methods were firstly developed for simultaneous determination of the two cited drugs in their co-formulated pharmaceutical capsule Methods: Alfuzosin, which is the major component in the dosage form, was directly assayed at its extended wavelength at 330.0 nm. The challenging spectrum of the minor component, solifenacin, was resolved by five spectrophotometric methods, namely; dual wavelength (DW) at 210.0 & 230.0 nm, first derivative (1D) at 222.0 nm, ratio difference (RD) at 217.0 - 271.0 nm , derivative ratio (1DD) at 223.0 and mean centering of ratio spectra (MC) at 217.0 nm Results: The Proposed methods were successfully validated as per ICH guidelines. Alfuzosin showed linearity over the range of 4.0 - 70.0 μg/mL, while that of solifenacin were 4.0 - 50.0 μg/mL for DW, 2.0 - 70.0 μg/mL for 1D and RD methods, 1.0 - 70.0 μg/mL for 1DD and 4.0 - 70.0 μg/mL for MC method. Statistical comparison with their official ones showed no noticeable differences. The methods showed good applicability for assaying drugs in their newly combination. Besides eco-scale, the greenness profile of the methods was assessed and compared with the reported spectrophotometric one via the newest metric tool; green analytical procedure index (GAPI). Conclusions: The proposed methods are superior in not only being smart, accurate, selective, robust and time-saving, but also in using distilled water as an eco-friendly and cheap solvent

scholarly journals Comparative Study of Novel Ratio Spectra and Isoabsorptive Point Based Spectrophotometric Methods: Application on a Binary Mixture of Ascorbic Acid and Rutin

2016 ◽  
Vol 2016 ◽  
pp. 1-12
Author(s):  
Hany W. Darwish ◽  
Ahmed H. Bakheit ◽  
Ibrahim A. Naguib
Keyword(s):  
Ascorbic Acid ◽  
Binary Mixture ◽  
High Performance ◽  
Pharmaceutical Tablets ◽  
Spectrophotometric Methods ◽  
First Derivative ◽  
Ratio Difference ◽  
Mean Centering ◽  
Assay Conditions

This paper presents novel methods for spectrophotometric determination of ascorbic acid (AA) in presence of rutin (RU) (coformulated drug) in their combined pharmaceutical formulation. The seven methods are ratio difference (RD), isoabsorptive_RD (Iso_RD), amplitude summation (A_Sum), isoabsorptive point, first derivative of the ratio spectra (1DD), mean centering (MCN), and ratio subtraction (RS). On the other hand, RU was determined directly by measuring the absorbance at 358 nm in addition to the two novel Iso_RD and A_Sum methods. The work introduced in this paper aims to compare these different methods, showing the advantages for each and making a comparison of analysis results. The calibration curve is linear over the concentration range of 4–50 μg/mL for AA and RU. The results show the high performance of proposed methods for the analysis of the binary mixture. The optimum assay conditions were established and the proposed methods were successfully applied for the assay of the two drugs in laboratory prepared mixtures and combined pharmaceutical tablets with excellent recoveries. No interference was observed from common pharmaceutical additives.

scholarly journals Three Spectrophotometric Methods for Quantitative Analysis of Duloxetine in Presence of its Toxic Impurity: 1-Naphthol

2020 ◽  
Vol 103 (4) ◽  
pp. 972-979 ◽  
Author(s):  
Ibrahim A Naguib ◽  
Nessreen S Abdelhamid ◽  
Basma H Anwar ◽  
Maimana A Magdy
Keyword(s):  
Pharmaceutical Formulations ◽  
Control Analysis ◽  
Aquatic Life ◽  
Spectrophotometric Methods ◽  
Duloxetine Hydrochloride ◽  
Ich Guidelines ◽  
Mean Centering ◽  
Absorbance Difference ◽  
The Mean

Abstract Background Duloxetine hydrochloride (DUL) is a drug used to treat depression and anxiety. 1-Naphthol is a potential toxic impurity of DUL, as it causes hepatotoxicity in humans, and it is harmful to aquatic life. Objective Three simple, selective, rapid, accurate and precise methods were developed and validated according to International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision and selectivity for analysis of duloxetine hydrochloride (DUL) in the presence of its potential toxic impurity 1-Naphthol in different laboratory-prepared mixtures and pharmaceutical formulations. Methods Method (A) is the first derivative of the ratio spectra spectrophotometric (1DD) method which allows determination of DUL at 251 nm and 1-Naphthol at 305.2 nm without interference from each other. Method B (dual wavelength) means that two different wavelengths were chosen to each drug, where the absorbance difference at these two wavelengths is equal to zero to the second drug. The chosen two wavelengths for DUL were 221.4 nm and 235.6, where the absorbance difference for 1-naphthol at these two wavelengths was equal to zero. While the chosen wavelengths for 1-naphthol were 247.8 nm and 297 nm, where the absorbance difference for DUL at these two wavelengths was equal to zero. Method (C) is the mean centering of ratio spectra spectrophotometric (MCR) method, which depends on measuring the mean centered values of ratio spectra of both DUL and 1-Naphthol at 226 nm. Results These methods were validated and agreed with the requirements of ICH guidelines with respect to linearity, accuracy, precision and selectivity. Conclusions The results indicate the ability of developed methods to be used for routine quality control analysis of DUL in bulk and pharmaceutical formulations in the presence of its potential impurity 1-Naphthol.

scholarly journals HPLC, Densitometric and Spectrophotometric Methods for the Simultaneous Determination of Colchicine and Probenecid in Their Binary Mixture

2019 ◽  
pp. 1-12 ◽  
Author(s):  
Samah Abd Elsabour Mohammed ◽  
Sawsan Abd El Moneim Abd El-Razeq ◽  
Israa Abd Elgafar Mohammed
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Binary Mixture ◽  
Mobile Phase ◽  
High Performance ◽  
Zero Order ◽  
Spectrophotometric Methods ◽  
Ratio Difference ◽  
Mean Centering

Aim: To develop methods with  complete validation according to ICH guidelines and to be  applied for the determination of both drugs in laboratory prepared mixtures and in pharmaceutical formulation Study Design: High performance liquid chromatography (HPLC), densitometric and different spectrophotometric methods (zero order, derivative ratio, ratio difference and mean centering) are developed for simultaneous determination of colchicine and probenecid in their combined pharmaceutical formulation.  Methodology: High performance liquid chromatography separation is developed using C18 column and methanol: ammonia (100: 1.5 v/v) as a mobile phase. The densitometric method based on the separation of both drugs using chloroform: methanol: ethyl acetate: water: ammonia (7: 5:2.5:0.5:0.5 by volume) as mobile phase and scanning λ at 254 nm. Zero order determination is based on measurement of colchicine absorbance at 349 nm.  The first derivative ratio of peak amplitudes at 367 nm& at 290.4 nm and the ratio difference with the amplitude difference between (385 nm and 362.4 nm) and ( 270 nm and 255 nm)  for colchicine and probenecid, respectively are developed for the determination of both drugs. Mean centering determination of probenecid is developed by measurement at 279 nm using 3.6 µg/mL of colchicine as a divisor. Results: HPLC method was applied over the  concentration ranges of 1.0-45.0 µg/mL & 0.5-30.0, while densitometric method was  linear over the concentration 0.15. 0-0.6 & 0.15-0.45 µg / band  and spectrophotometric methods were linear over the concentration ranges 10.00-55.0 & 3.6-20.0 µg/mL  for colchicine and probenecid, respectively. Conclusion: Novel, simple and accurate method for the determination of colchicine and probenecid simultaneously in their binary mixture.

scholarly journals Validated Stability Indicating HPTLC, UHPLC and UV-Spectrophotometric Techniques for the Determination of Bepotastine Besilate in Presence of Its Oxidative Degradate

2019 ◽  
pp. 1-14 ◽  
Author(s):  
Marwa Mohammed Soliman ◽  
Manal Kamal Darwish ◽  
Sawsan Abdel-Moneem Abdel-Razeq
Keyword(s):  
High Performance ◽  
Oxidative Degradation ◽  
Pharmaceutical Formulations ◽  
Stability Indicating ◽  
Spectrophotometric Methods ◽  
First Derivative ◽  
Ratio Difference ◽  
Ich Guidelines ◽  
Developing System

The study is aimed at developing methods which have a complete validation as stipulated in the ICH guidelines and to be applied for the determination of Bepotastine besilate (BB) in pure form and in pharmaceutical formulations in the presence of its oxidative degradation product. High performance thin layer chromatography (HPTLC), Ultra high performance liquid chromatography (UHPLC) and different spectrophotometric methods (first derivative, first derivative of ratio spectra and ratio difference are developed for simultaneous determination of bepotastine besilate in laboratory-prepared mixtures of bepotastine besilate with its oxidative degradate and in pharmaceutical formulations were used in the study design. Firstly, HPTLC was performed and separation occurred on silica gel 60 F254 plates, with butanol: ammonia (8:2, v/v) as a developing system. UHPLC in which separation occurred on a Kinetex C 18 column using methanol- 0.1% O-phosphoric acid - acetonitrile (70:20:10, by volume) as mobile phase, followed. And lastly was UV/Vis spectrophotometry which included first derivative determination of the drug at 252.6 nm, first derivative of ratio of peak amplitudes at 233.4, 250 and 275.6 nm and the ratio difference with the amplitude difference between (240 nm and 260 nm). Result showed that HPTLC method was applicable over the concentration range of 0.5-5 μg / band, while UHPLC method was linear over the concentration 2- 12 μg/mL and spectrophotometric methods were linear over the concentration range 20-120 μg/mL for bepotastine besilate. The proposed three techniques are quite accurate and precise. They can be used for routine analysis of bepotastine besilate in pharmaceutical formulation and stability indicating methods.

scholarly journals Manipulating Ratio Spectra for the Spectrophotometric Analysis of Diclofenac Sodium and Pantoprazole Sodium in Laboratory Mixtures and Tablet Formulation

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Nejal M. Bhatt ◽  
Vijay D. Chavada ◽  
Mallika Sanyal ◽  
Pranav S. Shrivastav
Keyword(s):  
Diclofenac Sodium ◽  
Pharmaceutical Preparations ◽  
Spectrophotometric Analysis ◽  
Control Analysis ◽  
Anova Analysis ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Mean Centering ◽  
Significant Difference

Objective. Three sensitive, selective, and precise spectrophotometric methods based on manipulation of ratio spectra, have been developed and validated for the determination of diclofenac sodium and pantoprazole sodium.Materials and Methods. The first method is based on ratio spectra peak to peak measurement using the amplitudes at 251 and 318 nm; the second method involves the first derivative of the ratio spectra (Δλ=4 nm) using the peak amplitudes at 326.0 nm for diclofenac sodium and 337.0 nm for pantoprazole sodium. The third is the method of mean centering of ratio spectra using the values at 318.0 nm for both the analytes.Results. All the three methods were linear over the concentration range of 2.0–24.0 μg/mL for diclofenac sodium and 2.0–20.0 μg/mL for pantoprazole sodium. The methods were validated according to the ICH guidelines and accuracy, precision, repeatability, and robustness are found to be within the acceptable limit. The results of single factor ANOVA analysis indicated that there is no significant difference among the developed methods.Conclusions. The developed methods provided simple resolution of this binary combination from laboratory mixtures and pharmaceutical preparations and can be conveniently adopted for routine quality control analysis.

scholarly journals Three Different Spectrophotometric Methods for Simultaneous Determination of Pyriproxyfen and Chlorothalonil Residues in Cucumber and Cabbage Samples

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Shilan A. Omer ◽  
Nabil A. Fakhre
Keyword(s):  
Simultaneous Determination ◽  
Simultaneous Estimation ◽  
Zero Crossing ◽  
Spectrophotometric Methods ◽  
First Derivative ◽  
The Third ◽  
Mean Centering ◽  
Relative Standard ◽  
One Way Anova

In this study, three simple and accurate spectrophotometric methods for simultaneous determination of pyriproxyfen and chlorothalonil residues in cucumbers and cabbages grown in experimental greenhouse were studied. The first method was based on the zero-crossing technique measurement for first and second derivative spectrophotometry. The second method was based on the first derivative of the ratio spectra. However, the third method was based on mean centering of ratio spectra. These procedures lack any previous separation steps. The calibration curves for three spectrophotometric methods are linear in the concentration range of 1–30 μg·mL−1 and 0.5–7 μg·mL−1 for pyriproxyfen and chlorothalonil successively. The recoveries ranged from 82.12–97.40% for pyriproxyfen and 81.51–97.04% for chlorothalonil with relative standard deviations less than 4.95% and 5.45% in all instances for pyriproxyfen and chlorothalonil, respectively. The results obtained from the proposed methods were compared statistically by using one-way ANOVA, and the results revealed there were no significant differences between ratio spectra and mean centering methods with the zero-crossing technique. The proposed methods are successfully applied for the simultaneous estimation of the residue of both pesticides in cucumber and cabbage samples.

scholarly journals Newly Developed Highly Sensitive Method for the Determination of Capecitabine by Using UV-Spectroscopy

2019 ◽  
Vol 11 (03) ◽  
Author(s):  
Manas Ranjan Mishra ◽  
Punam Agrawal ◽  
Surya Narayan Das
Keyword(s):  
Colon Cancer ◽  
Uv Spectroscopy ◽  
First Line ◽  
Spectrophotometric Methods ◽  
Advanced Colon Cancer ◽  
Ich Guidelines ◽  
Highly Sensitive ◽  
Solvent Systems ◽  
Sensitive Method

Capecitabine is a 'pro-drug' to the cytotoxic agent 5-fluorouracil (5-FU) intended to administered orally. Capecitabine is generally used as first line monotherapy for advanced colon cancer. Simple, rapid, accurate UV spectrophotometric methods were developed in the present study and validated for the estimation of Capecitabine in bulk and its formulations as per ICH guidelines. Three solvent systems viz., 0.1N NaOH, 0.1N HCl and Methanol: Water (1:3) was tried. The results suggest that the developed method shows linearity over the range of concentration 2-24μg/ml and a correlation coefficient of 0.9999. Accuracy, precision, linearity, robustness, and ruggedness were statistically validated as per ICH guidelines for all the developed methods. The % RSD values for validated methods were found to be less than 1.5 and methods will find application in routine analysis of drug formulations containing Capecitabine.

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 Zero order and area under curve spectrophotometric methods for determination of Levocetirizine in pharmaceutical formulation

2015 ◽  
Vol 1 (6) ◽  
pp. 270
Author(s):  
Audumbar Digambar Mali ◽  
Ritesh Bathe ◽  
Manojkumar Patil ◽  
Ashpak Tamboli
Keyword(s):  
Area Under The Curve ◽  
Zero Order ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Significant Difference ◽  
Curve Method ◽  
The Mean

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 zero order derivative values measured at 230 nm and the area under the curve method values measured at 227-234 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Levocetirizine using 5-25?g/ml (r=0.998 and r=0.999) for zero order and area under the 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. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Levocetirizine in tablets.

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.

Sign in / Sign up

Export Citation Format

Share Document