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 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 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 Determination of Tianeptine in Tablets by High-Performance Liquid Chromatography with Fluorescence Detection

2007 ◽  
Vol 90 (3) ◽  
pp. 720-724
Author(s):  
Sevgi Tatar Ulu
Keyword(s):  
Lower Limit ◽  
High Performance ◽  
Limit Of Detection ◽  
Internal Standard ◽  
Linear Calibration ◽  
Fluorescence Detector ◽  
Relative Standard ◽  
Validation Parameters ◽  
Limit Of Quantitation

Abstract A sensitive and selective high-performance liquid chromatographic method has been developed for the determination of tianeptine (Tia) in tablets. The method is based on derivatization of Tia with 4-chloro-7-nitrobenzofurazan (NBD-Cl). A mobile phase consisting of acetonitrile10 mM orthophosphoric acid (pH 2.5; 77 + 23) was used at a flow rate of 1 mL/min on a C18 column. The Tia-NBD derivative was monitored using a fluorescence detector, with emission set at 520 nm and excitation at 458 nm. Gabapentin was selected as an internal standard. Linear calibration graphs were obtained in the concentration range of 45300 ng/mL. The lower limit of detection (LOD) was 10 ng/mL at a signal-to-noise ratio of 4. The lower limit of quantitation (LOQ) was 45 ng/mL. The relative standard values for intra- and interday precision were <0.46 and <0.57%, respectively. The recovery of the drug samples ranged between 98.89 and 99.85%. No chromatographic interference from the tablet excipients was found. The proposed method was validated in terms of precision, robustness, recovery, LOD, and LOQ. All the validation parameters were within the acceptance range. The proposed method was applied for the determination of Tia in commercially available tablets. The results were compared with those obtained by an ultraviolet spectrophotometric method using t- and F-tests.

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 Development and Validation of UV-Spectrophotometric and HPLC Method determination of Dofetilide in Formulation

2020 ◽  
Vol 13 (2) ◽  
pp. 60-70
Author(s):  
Harsha Dhurve ◽  
Yasmini Parshuramkar ◽  
Milind Umekar ◽  
Krishna Gupta
Keyword(s):  
Detection Limit ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Limit Of Quantitation ◽  
Label Claim ◽  
Photodiode Array ◽  
Development And Validation ◽  
Good Agreement

A new, simple, specific and economic UV Spectrophotometric method and HPLC method for the estimation of Dofetilide content in bulk and laboratory prepared mixture. UV spectrophotometric detection was carried out at absorption maxima (λmax) at 231nm using methanol as a solvent. The quantitation of drug was carried out using A1% 1cm at 231nm and Beer’s law was obeyed in the concentration range of 2.5-20 μg/ml, with correlation coefficient value less than 1.The chromatographic separation was carried on a C-18 (250 mm × 4.6 mm, 5μ) column using an isocratic mode with a mixture of Acetonitrile:Phosphate Buffer (pH-7) in the ratio of 55:45% v/v as a mobile phase. The flow rate was 1.5ml/min, temperature is maintained at ambient and detection was made at 231 nm using Photodiode array (PDA) detector. The developed method was validated according to ICH guidelines and different analytical parameters such as linearity, precision, accuracy, specificity, limit of detection, limit of quantitation were determined. The percent amount of drug estimated was nearly 100%, found to be a good agreement with label claim of prepared laboratory mixture. The proposed method was validated for its accuracy, precision, robustness, ruggedness, linearity, limit of detection, limit of quantitation and was found to be in range (% RSD<2.0 and SD <±2.0). Both methods were validated and found to be simple, sensitive, accurate, and precise. The results of the study and statistical data proved the applicability of the present method in routine analysis of Dofetilide in bulk as well as laboratory prepared mixture.

QUANTITATIVE DETERMINATION OF RALOXIFENE HYDROCHLORIDE IN BULK AND TABLET FORMULATION BY UV-SPECTROPHOTOMETRY AND FIRST ORDER DERIVATIVE USING AREA UNDER CURVE METHOD

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (09) ◽  
pp. 40-43
Author(s):  
R. E Mutha ◽  
◽  
D. M Dhumal ◽  
P. H. Patil ◽  
A. A. Shirkhedkar ◽  
...  
Keyword(s):  
Spectrophotometric Method ◽  
Area Under Curve ◽  
Order Derivative ◽  
Uv Spectrophotometry ◽  
Uv Spectrum ◽  
First Order ◽  
Treatment And Prevention ◽  
Receptor Modulator ◽  
Raloxifene Hydrochloride

Raloxifene hydrochloride (RLF) is a non-steroidal, selective estrogen receptor modulator used in the treatment and prevention of osteoporosis in postmenopausal women. Two simple, rapid and economical 'zero order UV-spectrophotometric (method I)' and first order derivative spectrophotometric (method II) using area under curve (AUC) technique have been developed for estimation of RLF in bulk and tablets. In 0.1N NaOH, RLF showed maximum absorbance at 303.5 nm. In method I, AUC between two wavelengths 275.0 nm & 350.0 nm were selected. In method II, UV-spectrum of RLF was derivatized into first order and two wavelengths 303.0 nm and 385.0 nm were selected for determination of AUC. In both these methods, RLF obeyed linearity in the concentration range of 2-10 mcg/mL (r2>0.99). Proposed methods were applied for tablet formulations and amounts of RLF estimated by method I and method II were found to be 100.08±0.68 and 99.78±0.94, respectively. Both these methods were validated statistically and by recovery experiments.

A VALIDATED METHOD DEVELOPMENT FOR ESTIMATION OF SIMVASTATIN BY FIRST ORDER DERIVATIVE SPECTROSCOPY

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (11) ◽  
pp. 24-27
Author(s):  
S Dubey ◽  
◽  
S. S Shukla
Keyword(s):  
Aspergillus Terreus ◽  
Method Development ◽  
Order Derivative ◽  
First Order ◽  
Derivative Spectroscopy ◽  
Ich Guidelines ◽  
Trade Name ◽  
Elevated Cholesterol ◽  
Synthetic Derivative

Simvastatin is a hypolipidemic drug used with exercise, diet, and weight-loss to control elevated cholesterol, or hypercholesterolemia. It is a member of the statin class of pharmaceuticals. Simvastatin is a synthetic derivative of a fermentation product of Aspergillus terreus. The drug is marketed generically following the patent expiration, and under the trade name Zocor. The aim of this study is to develop a simple, accurate, precise and economical procedure for estimation of Simvastatin by first order derivative spectroscopy. The method is based upon determination of D1 value of the drug at, in Methanol. Different analytical performance parameters such as linearity, range, system precision, robustness, sensitivity and accuracy were determined according to the ICH guidelines. Simvastatin at its λ max shows linearity in the concentration range 10-60μg/mL.

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