DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF FAMOTIDINE, DICLOFENAC AND PARACETAMOL IN THEIR COMBINED DOSAGE FORM

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (09) ◽  
pp. 60-64
Author(s):  
P. P Desai ◽  
◽  
N. R. Patel ◽  
H. G Bhatt
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Simultaneous Equation ◽  
Simultaneous Estimation ◽  
Absorbance Measurement ◽  
Validation Parameters ◽  
Stock Solutions ◽  
Development And Validation ◽  
Tablet Dosage

Famotidine (FAM), Diclofenac (DCF) and Paracetamol (PCM) are used in combination for musculoskeletal disorders. A simple, sensitive, rapid, precise, reproducible and accurate spectrophotometric method for simultaneous determination of FAM, DCF and PCM was developed. The method was based on UV spectrophotometric determination of three drugs using simultaneous equation method. The stock solutions were prepared in methanol AR. Absorbance measurement was carried out at 288.4 nm, 281.2nm and 248.2 nm for FAM, DCF and PCM respectively. Beer Lambert law was obeyed in the concentration range of 1-30μg/mL for FAM, 2-40μg/mL for DCF and 1-20μg/mL for PCM. The results of the analysis were tested and validated for various validation parameters statistically and by recovery studies according to the International Conference on Harmonization Q2B guidelines. The utility of the developed method has been demonstrated by analysis of commercially available tablet dosage form.

scholarly journals Simultaneous Estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in Pharmaceutical Tablet Dosage Form by Simultaneous Equation Spectrophotometric Method: A Quality Control Tool for Dissolution Studies

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Deepak Sharma ◽  
Mankaran Singh ◽  
Dinesh Kumar ◽  
Gurmeet Singh
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Simultaneous Equation ◽  
Drug Formulation ◽  
Simultaneous Estimation ◽  
Validation Parameters ◽  
Quality Control Tool ◽  
Cetirizine Hydrochloride ◽  
Ambroxol Hydrochloride ◽  
Tablet Dosage

Ambroxol Hydrochloride and Cetirizine Hydrochloride are used for the treatment of bronchitis, cough, and allergy. A simple, economical, accurate, and precise method for simultaneous estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in tablet dosage form has been developed. Simultaneous equation method based on measurement of absorbance at two wavelengths, that is, 244 nm and 230 nm, λmax of Ambroxol Hydrochloride and Cetirizine Hydrochloride in pH 6.8 phosphate buffer. Both of these drugs obeyed Beer-Lambert’s law in the concentration range of 2–18 µg/mL for Ambroxol Hydrochloride and 2–20 µg/mL for Cetirizine Hydrochloride. The high values of correlation coefficient (R) indicated good linearity of calibration curve for both the drugs. The accuracy and precision of method were determined and the method was validated statistically. Result of percentage recovery study confirms the accuracy of proposed method. As per the ICH guidelines, the method validation parameters checked were linearity, accuracy, precision, and assay of drug formulation. Based on the results obtained, it can be concluded that the proposed simultaneous equation spectrophotometric method for simultaneous estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride is rapid, economical, accurate, precise, and reproducible. Hence, the proposed method can be employed for quantitative estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride from their tablet dosage form.

scholarly journals Simultaneous Spectrophotometric Method for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Three-Component Tablet Formulation Containing Rilpivirine Hydrochloride

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
S. Venkatesan ◽  
N. Kannappan
Keyword(s):  
Spectrophotometric Method ◽  
Analytical Method ◽  
Tenofovir Disoproxil Fumarate ◽  
Dosage Form ◽  
Simultaneous Equation ◽  
Equation Method ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Tablet Dosage

Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A complexation, derivatization, extraction, evaporation, and sensitive-free direct UV spectrophotometric method is developed and validated for the simultaneous estimation of some antiviral drugs such as emtricitabine (EMT), tenofovir disoproxil fumarate (TDF), and rilpivirine HCl (RPV) in tablet dosage form by Vierordt’s method. The solutions of standard and sample were prepared in methanol. The λmax⁡ for emtricitabine, tenofovir disoproxil fumarate, and rilpivirine hydrochloride were 240.8 nm, 257.6 nm, and 305.6 nm, respectively. Calibration curves are linear in the concentration ranges 4–12 μg/ml for EMT, 6–18 μg/ml for TDF, and 0.5–1.5 μg/ml for RPV, respectively. Results of analysis of simultaneous equation method were analyzed and validated for various parameters according to ICH guidelines.

scholarly journals Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Metformin and Glipizide in Tablet Dosage Form

2016 ◽  
Vol 1 (02) ◽  
pp. 56-59
Author(s):  
D. Sireesha ◽  
K. Ganesh ◽  
G. Nikitha ◽  
B. Vasudha
Keyword(s):  
Correlation Coefficient ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Simultaneous Equation ◽  
Simultaneous Estimation ◽  
Beer’S Law ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Detection And Quantification

A simple, rapid and precise spectrophotometric method has been developed for simultaneous estimation of Metformin and Glipizide. The method involved estimation of Metformin and Glipizide by simultaneous equation at 272nm and 232nm respectively in their solution in water. This method was validated with respect to linearity, accuracy, precision, LOD and LOQ. Beer’s law obeyed in the concentration range of 5-25μg/ml and 20-50μg/ml for Metformin and Glipizide respectively with the correlation coefficient of above 0.99. Limit of detection and quantification values were determined to be 0.214μg/ml and 0.649μg/ml for Metformin and 0.608μg/ml and 1.854μg/ml for Glipizide respectively. Mean recovery of Metformin and Glipizide were found to be in the range of 98-102% signifies the accuracy of the method. The method was found to be precise as %RSD was less than 2.

scholarly journals Development and Validation of UV Spectrophotometric Method for the Estimation of Cilnidipine and Valsartan in Bulk and Pharmaceutical Formulations

2019 ◽  
Vol 12 (4) ◽  
pp. 35-42
Author(s):  
Deshmukh Madhuri D ◽  
Deshmukh Supriya D
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Low Cost ◽  
Pharmaceutical Formulations ◽  
Simultaneous Equation ◽  
Simultaneous Estimation ◽  
Coefficient Of Correlation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Complex Extraction

A simple, rapid, accurate, precise, specific and economical spectrophotometric method for simultaneous estimation of Cilnidipine and Valsartan in combined tablet dosage form has been developed. Its employs Formation and solving of simultaneous equation using two wavelengths 240.20nm and 250nm using methanol as solvent. This method obeys Beers law in the employed concentration range 2-12μg /mL and 8-40 μg /mL for Cilnidipine and Valsartan respectively. Coefficient of correlation (R2) was 0.999for Cilnidipine and 0.999 for Valsartan. This method can be adopted in routine analysis of Cilnidipine and Valsartan in bulk and tablet dosage form and it involves relatively low cost solvent and no complex extraction technique.

SIMULTANEOUS ANALYSIS OF A THREE COMPONENT MIXTURE BY VIERODT’S SIMULTANEOUS EQUATION METHOD

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 40-42
Author(s):  
A Palekar ◽  
◽  
S. Gaude ◽  
S. P. N. Pai
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Drug Product ◽  
Simultaneous Equation ◽  
Simultaneous Equations ◽  
Simultaneous Estimation ◽  
Component Mixture ◽  
Percent Recovery ◽  
And Performance ◽  
Tablet Dosage

A simple, rapid, sensitive and economical UV spectrophotometric method was developed and validated for the simultaneous estimation of aspirin, caffeine, and orphenadrine citrate by Vierodt’s method in combined tablet dosage form and using mixture of 0.1 N HCl: ethanol (1:1) as solvent. The method employs designing and solving of simultaneous equations using 3 wavelengths, namely 226 nm, 272 nm, and 210 nm. Beer’s law was obeyed in the concentration range of 3-18 μg/mL for aspirin and 0.5-12 μg/mL for both caffeine and orphenadrine citrate with r2 value of 0.993, 0.991, and 0.991 respectively. Accuracy was determined by recovery studies and showed percent recovery ranging from 99.78-100% for aspirin, 96.10-100.92% for caffeine and 100.53-102.5% for orphenadrine citrate. The developed method can be used in QC laboratory for routine analysis to ensure the identity, purity, and performance of the drug product.

scholarly journals Simultaneous UV Spectrophotometric Estimation of Amlodipine and Chlorthalidone in Bulk and Combined Tablet Dosage Form

2019 ◽  
pp. 468-472
Author(s):  
Sunil More ◽  
Ashpak Tamboli ◽  
Snehal Patil ◽  
Amol Vhanmane
Keyword(s):  
Spectrophotometric Method ◽  
Mobile Phase ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Simultaneous Equation ◽  
Ich Guidelines ◽  
Combined Estimation ◽  
Tablet Dosage ◽  
Different Levels

There is not a single analytical methods appeared in the literature for combined estimation of Amlodipine and Chlorthalidone in tablets dosage form. Attempts were made to develop a simple, precise and accurate Simultaneous UV spectroscopic method of Amlodipine and Chlorthalidone in bulk and Amlodac CH tablet dosage form by using simultaneous equation method. UV spectrophotometric method was developed and validated as per ICH guidelines using methanol as mobile phase. Amlodipine and Chlorthalidone individually follows the Beer-Lamberts law over concentration range 2.5-12.5μg/ml and 6.25-31.5μg/ml, Regression of coefficient was found to be r2=0.999 and r2=0.999 respectively. The percentage recovery was found in the range of 98% to 102% at three different levels. The proposed method was successfully applied for the determination of Amlodipine and Chlorthalidone in tablets dosage form as per ICH guidelines the result of the analysis were validated statistically and were found to be satisfactory.

scholarly journals Development DEVELOPMENT AND VALIDATION OF NOVEL ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF DALFAMPRIDINE IN BULK AND IN PHARMACEUTICAL FORMULATION

2019 ◽  
pp. 275-279
Author(s):  
VAIBHAV S KHODKE ◽  
GAME MD
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Spectroscopic Method ◽  
Quality Criteria ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Good Agreement

Objective: The objective of the present study is to develop ultraviolet (UV)-spectroscopic method using pure drug and tablet dosage form that consistently produces a drug with a minimal variation that adheres to quality criteria of purity, identity, and potency. Methods: UV-spectrophotometric method has been developed using a solvent composed of methanol:water (30:70) as a diluent to determine the dalfampridine (DFP) content in bulk and pharmaceutical dosage form at predetermined λmax of 262 nm. Results: It was proved linear in the range of 02–12 μg/ml and exhibited a good correlation coefficient (r2 = 0.9915) and excellent mean recovery (0.004136347%). This method was successfully applied to the determination of DFP content of marketed tablet Dalstep 10 mg (Sun Pharmaceutical Pvt. Ltd.,) from India; the results were in good agreement with the label claims. Conclusion: The method proved to be simple, accurate, precise, specific, robust, and less time consuming and can be applied for the determination of DFP in bulk and marketed formulation.

scholarly journals NOVEL UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM

2019 ◽  
pp. 81-84
Author(s):  
VISHWAS T. S. ◽  
GURUPADAYYA B. M.
Keyword(s):  
Linear Relationship ◽  
Spectrophotometric Method ◽  
Calibration Curve ◽  
Dosage Form ◽  
Current Work ◽  
Validation Parameters ◽  
Line Equation ◽  
Tablet Dosage ◽  
Ich Guideline

Objective: The current work is intended towards the development of a novel, simple, and precise UV spectrophotometric method for the estimation of teriflunomide (TEF) present in the marketed formulation. Methods: Acetonitrile was used as asolvent and the absorbance of the drug was measured at the absorbance maxima of TEF, UV 284 nm. Results: Calibration curve plotted in concentration range 5-10 µg /ml exhibited excellent linear relationship with line equation y = 0.0858x-0.0223 and r2 value of 0.9996. The method was found to comply all the validation parameters as per the ICH guideline indicating the sensitivity of the method towards analyte. Conclusion: The method can be used satisfactorily for the routine analysis of TEF present in marketed formulation.

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