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 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 Stability-indicating liquid chromatographic and UV spectrophotometric methods for the quantification of ciprofibrate in capsules and tablets

2015 ◽  
Vol 51 (1) ◽  
pp. 221-231
Author(s):  
Fernanda Macke Hellwig ◽  
Rafael Henrique Dias Reis ◽  
Suzana Del Rosso Barbosa ◽  
Marcelo Donadel Malesuik
Keyword(s):  
Spectrophotometric Analysis ◽  
Array Detector ◽  
Control Analysis ◽  
Stability Indicating ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Photodiode Array Detector ◽  
Significant Difference ◽  
Photodiode Array ◽  
Liquid Chromatographic

This study describes the development and evaluation of stability-indicating liquid chromatographic (LC) and UV spectrophotometric methods for the quantification of ciprofibrate (CPF) in tablets and capsules. Isocratic LC separation was achieved on a RP18 column using a mobile phase of o-phosphoric acid (0.1% v/v), adjusted to pH 3.0 with triethylamine (10% v/v) and acetonitrile (35:65 v/v), with a flow rate of 1.0 mL min-1. Detection was achieved with a photodiode array detector at 233 nm. For the spectrophotometric analysis, ethanol and water were used as the solvent and a wavelength of 233 nm was selected for the detection. The methods were validated according to International Conference on Harmonization (ICH) guidelines for validating analytical procedures. Statistical analysis showed no significant difference between the results obtained by the two methods. The proposed methods were successfully applied to the CPF quality-control analysis of tablets and capsules.

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 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.

scholarly journals Estimation of Ofloxacin in Bulk and Formulation by Second Order DerivativeUV-Spectrophotometric Methods

2015 ◽  
Vol 1 (5) ◽  
pp. 217
Author(s):  
Shivaji Shinde ◽  
Santosh Jadhav ◽  
Rekha Kharat ◽  
Afaque Ansari ◽  
Ashpak Tamboli
Keyword(s):  
Area Under Curve ◽  
Pharmaceutical Formulations ◽  
Second Order ◽  
Order Derivative ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Significant Difference

Simple, fast and reliable spectrophotometric methods were developed for determination of Ofloxacin 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 295-301nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ofloxacin using 2-10?g/ml (r=0.9947) 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 Ofloxacin in pharmaceutical formulations.

scholarly journals Kinetic Spectrophotometric Determination of Gemifloxacin Mesylate and Moxifloxacin Hydrochloride in Pharmaceutical Preparations Using 4-Chloro-7-nitrobenzo-2-oxa-1,3-diazole

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Mohammed G. Abdel Wahed ◽  
Ragaa El Sheikh ◽  
Ayman A. Gouda ◽  
Sayed Abou Taleb
Keyword(s):  
Limit Of Detection ◽  
Kinetic Method ◽  
Pharmaceutical Preparations ◽  
Fixed Time ◽  
Spectrophotometric Methods ◽  
Relative Standard ◽  
Significant Difference ◽  
Kinetic Spectrophotometric ◽  
Comparison Of The Results

Simple, sensitive, and accurate kinetic spectrophotometric method was proposed for the determination of gemifloxacin mesylate (GMF) and moxifloxacin hydrochloride (MOX) in pure forms and pharmaceutical preparations (tablets). The method is based on coupling the studied drugs with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) in the presence of alkaline borate buffer. Spectrophotometric measurement was achieved by recording the absorbance at 466 and 464 nm for GMF and MOX, respectively, after a fixed time of 20 and 15 min on a water bath adjusted at 70 ± 5°C for both drugs. The different experimental parameters affecting the development and stability of the color were carefully studied and optimized. The absorbance-concentration plots were linear over the ranges 0.5–8.0 and 2.0–12 μg mL−1for GMF and MOX, respectively. The limit of detection of the kinetic method was about 0.12 (2.47 × 10−7 M) and 0.36 (8.22 × 10−7 M) μg mL−1for GMF and MOX, respectively. The proposed methods have been applied and validated successfully with percentage relative standard deviation (RSD% ≤ 0.52) as precision and percentage relative error (RE% ≤ 1.33) as accuracy. The robustness of the proposed method was examined with recovery values that were 97.5–100.5 ± 1.3–1.9%. Statistical comparison of the results with the reference spectrophotometric methods shows excellent agreement and indicates no significant difference in accuracy or precision.

scholarly journals RP-HPLC AND CHEMOMETRIC METHODS FOR THE DETERMINATION OF TWO ANTI-DIABETIC MIXTURES; METFORMIN HYDROCHLORIDE-CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE-GLICLAZIDE IN THEIR PHARMACEUTICAL FORMULATION

2019 ◽  
pp. 83-94
Author(s):  
MALAK Y. AL-BATHISH ◽  
AZZA A. GAZY ◽  
MARWA K. EL-JAMAL
Keyword(s):  
Binary Mixtures ◽  
Potassium Dihydrogen Phosphate ◽  
Pharmaceutical Preparations ◽  
Reversed Phase ◽  
Metformin Hydrochloride ◽  
Dihydrogen Phosphate ◽  
Control Analysis ◽  
Spectrophotometric Methods ◽  
Rp Hplc

Objective: To develop and validate novel more sensitive analytical methods for the concurrent quantification of metformin-canagliflozin and metformin-gliclazide in their bulk forms and in their pharmaceutical preparations. Methods: Two methods were developed based on several chemometric assisted spectrophotometric methods and a Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC). The first method applies different spectrophotometric chemometric assisted methods, including ratio difference, derivative ratio and extended ratio subtraction method, while the second method describes a RP-HPLC separation of metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide binary mixtures using a C18 column with a mobile phase consisting of acetonitrile: potassium dihydrogen phosphate (adjusted to pH 3) with sodium lauryl sulphate as additive in the ratio of 30:70 (%v/v) in isocratic elution mode at 1 ml/min. Results: The proposed methods were able to quantify each of the studied drugs in their binary mixtures with high percentage recoveries in both methods. The spectrophotometric methods were able to quantify each of metformin, canagliflozin and gliclazide in the ranges of 2.0-20.0 μg/ml, 1.5-40.0 μg/ml and 2.0-30.0 μg/ml, respectively. The RP-HPLC method produced well-resolved peaks at a retention time of 3.92, 6.92 and 9.10 min in the concentration ranges of 50.0-300.0 μg/ml, 5.0-50.0 μg/ml and 10.0-100.0 μg/ml for metformin, canagliflozin and gliclazide, respectively. The proposed methods were optimized and validated in accordance to the International Conference of Harmonisation (ICH) guidelines in terms of linearity, LOD, LOQ, precision and accuracy. Conclusion: The developed methods were found to be sensitive and reproducible methods for the simultaneous determination of anti-diabetic binary mixtures; metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide. And thus were successfully employed for the quality control analysis of the pharmaceutical formulations of the studied binary mixtures.

New, simple and validated UV-spectrophotometric methods for the estimation of sodium usnate in preparations

2010 ◽  
Vol 29 (2) ◽  
pp. 157 ◽  
Author(s):  
Ivana Savić ◽  
Goran Nikolić ◽  
Ivan Savić ◽  
Saša Zlatković ◽  
Dragiša Djokić
Keyword(s):  
Phosphate Buffer ◽  
Pharmaceutical Preparations ◽  
High Sensitivity ◽  
Cost Effective ◽  
Sensitivity Coefficient ◽  
Molar Absorptivity ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Beer’S Law

New, simple, cost effective, accurate and reproducible UV-spectrophotometric methods were developed and validated for the estimation of sodium usnate in pharmaceutical preparations. Sodium usnate was estimated at 290 nm in water and phosphate buffer (pH 3):methanol (11:20 V/V). Beer’s law was obeyed in the concentration range of 0.1–5 μg·cm−3 (r = 0.997) in water and 1–12 μg·cm−3 (r = 0.999) in the phosphate buffer:methanol. The apparent molar absorptivity and Sandell’s sensitivity coefficient were found to be 3.16×104 dm3·mol−1·cm−1 and 11.58 ng·cm–2/0.001 A in water and 3.72×104 dm3·mol−1·cm−1 and 9.83 ng·cm–2/0.001 A in phosphate buffer:methanol, respectively, indicating the high sensitivity of the proposed methods. These methods were tested and validated for various parameters according to ICH guidelines. The detection and quantitation limits were found to be 0.0721 and 0.2163 μg·cm–3 in water and 0.163, 0.489 μg·cm−3 in phosphate buffer:methanol, respectively. The proposed methods were successfully applied for the determination of sodium usnate in pharmaceutical preparations. The results demonstrated that the procedure is accurate, precise and reproducible (R.S.D. < 2 %).

scholarly journals Of bromination reaction for the spectrophotometric assay of domperidone in pharmaceuticals

2011 ◽  
Vol 17 (1) ◽  
pp. 81-89 ◽  
Author(s):  
Zenita Devi ◽  
K. Basavaiah ◽  
K.B. Vinay
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Preparations ◽  
Reference Method ◽  
Standard Addition ◽  
Limit Of Quantification ◽  
Fixed Amount ◽  
Spectrophotometric Methods ◽  
Significant Difference ◽  
Bulk Drug

Three simple and sensitive spectrophotometric methods are described for the determination of domperidone (DOM) in bulk drug and in dosage forms using bromate-bromide mixture as brominating agent in acid medium and three dyes, meta-cresol purple (MCP), amaranth (AMR) and erioglaucine (EGC). The methods involve the addition of a known excess of bromate-bromide mixture to an acidified solution of DOM followed by the determination of the residual bromine by reacting with a fixed amount of either MCP dye and measuring the absorbance at 530 nm (method A) or AMR dye and measuring the absorbance at 520 nm (method B) or EGC dye and measuring the absorbance at 630 nm (method C). Beer?s law is obeyed over the concentration ranges, 0.63 - 10.0, 0.25-4.0 and 0.13-2.0 ?g mL-1 for method A, method B and method C, respectively. The apparent molar absorptivities are calculated to be 3.751 ? 104, 6.604 ? 104 and 1.987 ? 105 L mol-1cm-1 for method A, method B and method C, respectively and the corresponding sandell sensitivity values are 0.011, 0.006 and 0.002 ?g cm-2. The limit of detection and the limit of quantification are also reported for all the three methods. No interference was observed from common additives found in pharmaceutical preparations. Statistical comparisons of the results with those of the reference method showed an excellent agreement, and indicated no significant difference in accuracy and precision. The accuracy and reliability of the methods were further ascertained by performing recovery tests via standard-addition technique.

Sign in / Sign up

Export Citation Format

Share Document