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 A Sensitive UV Spectrophotometric Method for the Determination of Gabapentin

2009 ◽  
Vol 6 (s1) ◽  
pp. S163-S170 ◽  
Author(s):  
R. Singh Gujral ◽  
S. Manirul Haque ◽  
P. Shanker
Keyword(s):  
Spectrophotometric Method ◽  
Good Accuracy ◽  
Limit Of Detection ◽  
Low Cost ◽  
Pharmaceutical Formulations ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Precision Limit

An accurate and validated spectrophotometric method was developed for the determination of gabapentin. This is simple, sensitive and low cost UV spectrophotometric method. The method is based on the direct measurement of the native absorbance of the drug. The detection was done at 210 nm. The method was linear in the range of 0.25 - 3.5 µ g/mL with correlation coefficient of 0.9999. It is validated according to the ICH guidelines with respect to linearity, selectivity, accuracy and precision, limit of quantitation and limit of detection. The method has been applied to assess gabapentin in pharmaceutical formulations with good accuracy and precision and relatively free of interference from coexisting substances.

scholarly journals Development and validation of UV-spectrophotometric methods for quantitative estimation of Prothionamide in pure and pharmaceutical dosage forms

2015 ◽  
Vol 4 (7) ◽  
pp. 402-404 ◽  
Author(s):  
Sujit Kumar Debnath ◽  
S. Saisivam ◽  
Dillip Kumar Dash ◽  
Monalisha Debnath
Keyword(s):  
Quantitative Estimation ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
Routine Practice ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Validation Parameters ◽  
Bulk Drug ◽  
Development And Validation

UV Spectrophotometric method was developed and validated for the quantitative determination of Prothionamide in bulk drug and in pharmaceutical formulations. Prothionamide shows the maximum absorbance at 288 nm in phosphate buffer (pH 7.4). Prothionamide follows Beer’s law in the concentration range of 4-20 µg/ml (r2 = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.406 and 1.229 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 Prothionamide in assay of bulk drug and pharmaceutical formulations.International Current Pharmaceutical Journal, June 2015, 4(7): 402-404

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 Spectrophotometric Determination of Olmutinib in Bulk by Area under Curve and First Order Derivative Methods and its Validation as per ICH guidelines

2019 ◽  
Vol 9 (4-A) ◽  
pp. 349-354
Author(s):  
BALU KHANDARE ◽  
Atish C. Musle ◽  
Sanket S. Arole ◽  
Pravin V. Popalghat
Keyword(s):  
Area Under Curve ◽  
Limit Of Detection ◽  
Order Derivative ◽  
Spectrometric Method ◽  
First Order ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Limit Of Quantitation

Abstract: A simple, precise and economical UV-spectrophotometric method has been developed for the estimation of Olmutinib from bulk. Two methods were developed First method (A) applied was area under curve (AUC) in which the area was integrated in wavelength from 262-272nm. Second method (B) was first order derivative spectrometric method. In this method absorbance at λmin=256.57nm, λmax=282.83nm and zero cross=267.68nm was measured. Calibration curves were plotted for the method by using instrumental response at selected wavelength and concentration of analyte in the solution. In both the methods, linearity was observed in the concentration range of 2-12µg/ml at the λmax=267.68nm. Accuracy and precision studies were carried out and results were satisfactorily obtained. The drug at each of the 80 %, 100 % and 120 % levels showed good recoveries that is in the range of 98.00 to 99.00% for both methods, hence it could be said that the method was accurate. Limit of detection (LOD) and limit of quantitation (LOQ) were determined for the method. The method was validated as per International Conference on Harmonization. All validation parameters were within the acceptable limit. The developed method was successfully applied to estimate the amount of Olmutinib in pharmaceutical formulation.

scholarly journals DEVELOPMENT AND VLAIDATION OF SIMPLE UV-SPECTROPHOTOMETRIC METHOD OF QUANTIZATION OF DIAZEPAM IN BULK DRUG AND SOLID DOSAGE FORMULATION USING MIXED SOLVENCY CONCEPT

2017 ◽  
Vol 9 (6) ◽  
pp. 15
Author(s):  
Sanjay Jain ◽  
R. K. Maheshwari ◽  
R. K. Nema ◽  
Indrajeet Singhvi
Keyword(s):  
Organic Solvents ◽  
Spectrophotometric Method ◽  
Spectrophotometric Analysis ◽  
Control Analysis ◽  
Solid Dosage ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Insoluble Drugs ◽  
Benzene Toluene ◽  
Bulk Drug

Objective: Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs are methanol, ethanol, chloroform, benzene, toluene etc. The main drawbacks of organic solvents include high cost, toxicity, and pollution. Organic solvents have numerous adverse effects caused by single exposure like dermatitis, headache, drowsiness, nausea, eye irritation and long term exposure causes serious effects such as neurological disorder, chronic renal failure, and liver damage. They should be replaced by other ecofriendly alternative sources.Methods: The present study is an attempt to show that solid can also be used to act as solvent precluding the use of organic solvents. A simple, safe and sensitive method of spectrophotometric determination of diazepam obeyed beers law in the concentration range of 5-25 mcg/ml at 306 nm.Results: The results of analyses have been validated statistically for Linearity, accuracy, precision, LOD and LOQ. The results of validation parameters also indicated that proposed method was found to be accurate, precise, reproducible, sensitive, and suitable for routine quality control analysis for estimation of diazepam in bulk drug and solid dosage formulation.Conclusion: A rapid, simple, and non toxic UV spectrophotometric method has been developed for the determination and quantification of diazepam. The present method also validated as per ICH guidelines for linearity, precision, accuracy.

scholarly journals Application of Cerium (IV) as an Oxidimetric Agent for the Determination of Ethionamide in Pharmaceutical Formulations

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Kanakapura Basavaiah ◽  
Nagib A. S. Qarah ◽  
Sameer A. M. Abdulrahman
Keyword(s):  
Quality Control ◽  
Pharmaceutical Formulations ◽  
Molar Absorptivity ◽  
Sample Solution ◽  
Standing Time ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Back Titration ◽  
Bulk Drug

Two simple methods are described for the determination of ethionamide (ETM) in bulk drug and tablets using cerium (IV) sulphate as the oxidimetric agent. In both methods, the sample solution is treated with a measured excess of cerium (IV) solution in H2SO4 medium, and after a fixed standing time, the residual oxidant is determined either by back titration with standard iron (II) solution to a ferroin end point in titrimetry or by reacting with o-dianisidine followed by measurement of the absorbance of the orange-red coloured product at 470 nm in spectrophotometry. In titrimetry, the reaction proceeded with a stoichiometry of 1 : 2 (ETM : Ce (IV)) and the amount of cerium (IV) consumed by ETM was related to the latter’s amount, and the method was applicable over 1.0–8.0 mg of drug. In spectrophotometry, Beer’s law was obeyed over the concentration range of 0.5–5.0 μg/mL ETM with a molar absorptivity value of 2.66 × 104 L/(mol·cm). The limits of detection (LOD) and quantification (LOQ) calculated according to ICH guidelines were 0.013 and 0.043 μg/mL, respectively. The proposed titrimetric and spectrophotometric methods were found to yield reliable results when applied to bulk drug and tablets analysis, and hence they can be applied in quality control laboratories.

scholarly journals Development of Analytical Profile of Lamotrigine and its API Formulation

2021 ◽  
pp. 111-114
Author(s):  
VISHAL CHAUDHARY ◽  
VASUNDHARA SAXENA
Keyword(s):  
Spectrophotometric Method ◽  
Quantitative Estimation ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Rp Hplc ◽  
System Suitability ◽  
Bulk Drug

Objective: The objective of this review is to put a light on the development of lamotrigine and its active pharmaceutical ingredients formulation with proper demonstration. Method: In the present work, one of the most imperative spectrophotometric method which is RP-HPLC method has been developed for the quantitative estimation of lamotrigine in bulk and pharmaceutical formulations. UV spectrophotometric method which involves the determination of Lamotrigine in bulk and in bulk drug and pharmaceutical formulation has maximum absorption at 307.5nm in methanol. It obeys Beer’s and Lambert’s law in the concentration range of 5-45 µg/ml. A rapid and sensitive RP- HPLC Method with UV detection (270 nm) for routine analysis of Lamotrigine formulation was developed. Chromatography was performed with mobile phase containing a mixture of methanol and Phosphate buffer (65:35v/v) with flow rate 1.0 ml/min. In the range of 20-100 µg/ml, the linearity of lamotrigine shows a correlation co-efficient of 0.9998. The proposed method was validated by determining sensitivity and system suitability parameters.

scholarly journals The simultaneous spectrophotometric determination of trimazolin and phenylephrine hydrochloride in nasal preparations

2008 ◽  
Vol 14 (4) ◽  
pp. 261-264 ◽  
Author(s):  
Ivana Savic ◽  
Goran Nikolic ◽  
Ivan Savic ◽  
Vladimir Bankovic
Keyword(s):  
Spectrophotometric Determination ◽  
Pharmaceutical Formulations ◽  
Active Components ◽  
Phenylephrine Hydrochloride ◽  
Drug Substances ◽  
Accuracy And Precision ◽  
Ich Guidelines ◽  
Relative Standard ◽  
High Degree

This paper presents the experimental results for the simultaneous spectrophotometric determination of two active components in nasal solutions. The resolution of two-component mixtures of timazolin and phenylephrine has been accomplished by using partial least-squares. The method comprised of the absorptivity measurement in a nasal solution at wavelengths of 265 and 272 nm, respectively. Notwithstanding the presence of two components and their high degree of spectral overlap, they have been determined simultaneously with high accuracy and precision, with no interference, rapidly and without resorting to extraction procedures using non aqueous solvents. This method was tested and validated for various parameters according to ICH guidelines. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2 %), while being simple, cheap and less time consuming. The method was applied for the analysis of these drug substances in their commercial pharmaceutical formulations.

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 Spectrophotometric Determination of Some Antihistaminic Drugs Using 7,7,8,8-Tetracyanoquinodimethane (TCNQ)

2006 ◽  
Vol 89 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Amr M Badawey ◽  
Samah S Abbas ◽  
Hayam M Loutfy
Keyword(s):  
Spectrophotometric Determination ◽  
Spectrophotometric Method ◽  
Good Accuracy ◽  
Pharmaceutical Formulations ◽  
European Pharmacopoeia ◽  
Accuracy And Precision ◽  
Antihistaminic Drugs ◽  
Assay Conditions ◽  
Sensitive Spectrophotometric Method

Abstract A simple and sensitive spectrophotometric method is suggested for analysis of 3 antihistaminic drugs, acrivastine (I), mequitazine (II), and dimethindene maleate (III). The method is based on reaction of the drugs with 7,7,8,8-tetracyanoquinodimethane (TCNQ) in acetonitrile to form highly stable colored products that are measured at 750, 766, and 844 nm for I and II, and 480 and 618 nm for III. Beer's law is obeyed in the ranges of 560 g/mL for I, 550 g/mL for II, and 1070 g/mL for III. The optimum assay conditions and their applicability to the determination of the cited drugs in pharmaceutical formulations are described. The method is statistically analyzed as compared with the European Pharmacopoeia (2001) method for the analysis of dimethindene maleate and reference methods for acrivastine and mequitazine drugs revealing good accuracy and precision.

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