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

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.

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Parth R. Joshi ◽  
Shraddha J. Parmar ◽  
Bhavna A. Patel

Salbutamol sulfate and ketotifen fumarate are used in combination for the treatment of asthma. The present work deals with method development for simultaneous estimation of salbutamol sulfate and ketotifen fumarate in two-component tablet formulation by first-order derivative spectroscopy. For determination of sampling wavelength, 10 μg/mL of each of salbutamol and ketotifen was scanned in 200–400 nm ranges and sampling wavelengths were found to be 257 nm for salbutamol and 278 nm for ketotifen in first-order derivative spectroscopy. In this method, linearity was observed in the ranges of 5–45 μg/mL for salbutamol and 5–35 μg/mL for ketotifen. The % recovery was within the range between 98 and 102%, and % relative standard deviation for precision and accuracy of the method was found to be less than 2%. The method is validated as per international conference on harmonization guidelines. The method can be successfully applied for the simultaneous analysis of both drugs in pharmaceutical dosage forms.


2021 ◽  
Vol 14 (2) ◽  
pp. 029-036
Author(s):  
Wrushali A. Panchale ◽  
Ravindra L. Bakal

Aim of present work was to develop and validate a simple, precise and accurate uv-vis spectrophotometric method for the simultaneous estimation of gemifloxacin mesylate (GEMI) and ambroxol HCl (AMB) in their combined tablet dosage form. The method is based on first-order derivative spectroscopy. For determination of sampling wavelengths, each of GEMI and AMB were scanned in the wavelength range of 200–400 nm in the spectrum mode and sampling wavelengths were selected at 360 nm (zero crossing of GEMI) where AMB showed considerable absorbance and at 221.6 nm (zero crossing of AMB) where GEMI showed considerable absorbance. The linearity was obtained in the concentration range of 32-192 µg/ml for GEMI and 7.5-45 µg/ml for AMB. The correlation coefficients were found to be 0.9987 and 0.9992 for GEMI and AMB, respectively. The method was validated as per ICH guidelines. Mean recoveries were found satisfactory. All the data of validation study was found to be satisfactorily. The proposed method can be applied for simultaneous estimation of both the drugs


2019 ◽  
Vol 9 (4-A) ◽  
pp. 349-354
Author(s):  
BALU KHANDARE ◽  
Atish C. Musle ◽  
Sanket S. Arole ◽  
Pravin V. Popalghat

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.


2016 ◽  
Vol 2 (1) ◽  
pp. 09
Author(s):  
Pandurang Tukaram Mane

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.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (01) ◽  
pp. 87-90
Author(s):  
S Raghu ◽  
S. Muneer. ◽  
K.B. Chandra sekhar ◽  
kiran B. Siva Sai ◽  

The present study was carried out to develop a simple and reliable derivative spectrophotometric method for the determination of bromofenac sodium in pharmaceutical dosage forms .The solutions of standard and the sample were prepared in distilled water The quantitative determination of the drug was carried out with zero order derivative (method A) values measured at 268 nm and first order (method B) derivative values measured at 258 nm , and two wavelengths 262nm and 274nm were selected for the determination AUC (method C) of integrated areas. Calibration graphs constructed at their wavelengths of determination, were linear within the concentration range of 2-12 μg/mL (r2 = 0.999) for zero order and (r2 = 0.997) first order derivative spectrophotometric method. No significant difference between the performance of the proposed methods regarding the mean values and standard deviations and is suitable for the routine quality control application of bromofenac sodium in its pharmaceutical formulations.


INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 40-44
Author(s):  
S. B. Ganorkar ◽  
◽  
D. M Dhumal ◽  
A. A Shirkhedkar

Zileuton is an orally active inhibitor of 5-lipoxygenase and found to inhibit leukotrienes (LTB4 , LTC4, LTD4 , and LTE4) formation and well-known for the effective treatment of asthma. Rapid, economical and simple ‘Zero order UV-spectrophotometry’ and ‘First order derivative UV-spectrophotometry’ have been developed for estimation zileuton in bulk and in-house tablets. Zileuton showed maximum absorbance at 258.4 nm in 0.01M NaOH. For Zero order UV-spectrophotometric method (Method I), two wavelengths 243.4 nm and 271.0 nm were selected for the determination of area under curve (AUC). In First order derivative UV-spectrophotometry (Method II), two wavelengths 260.0 nm and 279.60 nm were selected for determination of AUC. For both these methods, zileuton followed linearity in the concentration range of 4 - 24 µg/ mL with correlation coefficient value of 0.999. Both methods were validated as per ICH guidelines.


Author(s):  
Pratik S Mehta ◽  
Pratik R. Patel ◽  
Rajesh R Parmar ◽  
M M K Modasiya ◽  
Dushyant A Shah

A novel, simple, accurate, sensitive, precise and economical derivative spectroscopic method was developed and validated for the determination of cefadroxil and probenecid in synthetic mixture. First order derivative spectroscopy method was adopted to eliminate spectral interference. The method obeys Beer’s Law in concentration ranges of 4-36 μg/ml for cefadroxil and of 5-25 μg/ml of probenecid. The zero crossing point for cefadroxil and probenecid was 260 nm and 237.8 nm respectively in 0.1N HCl. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation. This method has been successively applied to synthetic mixture and no interference from the synthetic mixture’s excipients was found.   


2014 ◽  
Vol 2014 ◽  
pp. 1-13 ◽  
Author(s):  
Vu Dang Hoang ◽  
Dong Thi Ha Ly ◽  
Nguyen Huu Tho ◽  
Hue Minh Thi Nguyen

The application of first-order derivative and wavelet transforms to UV spectra and ratio spectra was proposed for the simultaneous determination of ibuprofen and paracetamol in their combined tablets. A new hybrid approach on the combined use of first-order derivative and wavelet transforms to spectra was also discussed. In this application, DWT (sym6 and haar), CWT (mexh), and FWT were optimized to give the highest spectral recoveries. Calibration graphs in the linear concentration ranges of ibuprofen (12–32 mg/L) and paracetamol (20–40 mg/L) were obtained by measuring the amplitudes of the transformed signals. Our proposed spectrophotometric methods were statistically compared to HPLC in terms of precision and accuracy.


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