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.

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.

Novel UV Spectrophotometric Method for the Quantitative Analysis of CefpodoximeProxetil in Pharmaceutical Formulations by First Derivative Technique

2017 ◽  
Vol 8 (03) ◽  
Author(s):  
Potdar S. S. ◽  
Karajgi S. R. ◽  
Simpi C. C. ◽  
Kalyane N. V.
Keyword(s):  
Quantitative Analysis ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
First Derivative ◽  
Good Linearity ◽  
Beer's Law ◽  
Beer’S Law ◽  
Tablet Dosage ◽  
Ich Guideline

The spectrophotometric method for estimation of CefpodoximeProxetil employed first derivative amplitude UV spectrophotometric method for analysis using methanol as solvent for the drug. CefpodoximeProxetil has absorbance maxima at 235nm and obeys Beer’s law in concentration range 10-50µg/ml with good linearity i.e. r2 about 0.999. The recovery studies established accuracy of the proposed method; result validated according to ICH guideline. Results were found satisfactory and reproducible. The method was successfully for evaluation of CefpodoximeProxetil in tablet dosage form without interference of common excipients.

scholarly journals DETERMINATION OF THIAMINE HCL (VITAMIN B1) AND PYRIDOXINE HCL (VITAMIN B6) CONTENT IN TABLET BY FTIR

2016 ◽  
Vol 8 (10) ◽  
pp. 257 ◽  
Author(s):  
Ilma Nugrahani ◽  
Citra Kartini
Keyword(s):  
Vitamin B6 ◽  
Dosage Form ◽  
Vitamin B1 ◽  
Area Under The Curve ◽  
Thiamine Hydrochloride ◽  
Compound Identification ◽  
Quantitation Limit ◽  
Validation Parameters ◽  
Tablet Dosage

<p><strong>Objective: </strong>The combination of thiamine hydrochloride (vitamin B1) with pyridoxine hydrochloride (vitamin B6) has been efficacious to help the metabolism of carbohydrates and amino acids. FTIR (Fourier transform infrared) is a technique widely used in compound identification and determination of functional groups but rarely used for the quantitative purposes. This study aims to obtain a analysis determination method of this vitamin combination simultaneously in tablet dosage form using FTIR.</p><p><strong>Methods: </strong>Amount of vitamin B1 and B6 standard were mixed with KBr crystal in a series of concentration (% w/w) in kalium bromide (kbr) crystal, then measured with FTIR. These spectrums yielded were transformed into an absorbance afterward changed to its derivative. The finest spectrum, which showed the best specificity and linearity, was selected and its area under the curve was calculated. The other validation parameters: accuracy, precision, detection limit, quantitation limit, and ranges, next were tested and determined. The validated method than was used to analyze the levels of vitamin B1 and B6 simultaneously in the tablets.</p><p><strong>Results: </strong>Vitamin B1 and B6 have the linear concentration range from 0.5 to 3.00% w/w. The regression equation for vitamin B1 is y = 0.0608 x-0.0176 with r = 0.9997 and Vx0 = 1.5047%, for vitamin B6: y = 0.0977 x+0.0079 r = 0.9995 and Vx0 = 1.7832%. Recovery results of vitamin B1: 98.98 to 100.93%, while B6: 99.06 to 100.43%. Intra-day and inter-day precision for vitamin B1: 1.73; 1.62; 1.48, and 0.58%, meanwhile for vitamin B6: 1.29; 1.60; 1.78, and 1.39%. The limits of detection and quantitation for vitamin B12 was 0.079 and 0.263% w/w respectively, and for vitamin B6, was: 0.093 and 0.311% w/w. The tablets from the market were tested showed the results that meet with compendia requirements.</p><p><strong>Conclusion: </strong>FTIR can be used for the determination of levels of vitamin B1 and B6 simultaneously in tablet dosage form and have met the validation requirements.</p>

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 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 DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF GUAIFENESIN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL IN TABLET DOSAGE FORM

2018 ◽  
Vol 11 (13) ◽  
pp. 1
Author(s):  
Fitria Adriani ◽  
Muchlisyam Muchlisyam ◽  
Siti Morin Sinaga
Keyword(s):  
Dosage Form ◽  
Derivative Spectrophotometry ◽  
Diphenhydramine Hydrochloride ◽  
Validation Parameters ◽  
Recovery Study ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Selection Of

 Objective: This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of guaifenesin (GUA), dextromethorphan hydrobromide (DMP), and diphenhydramine hydrochloride (DPH) in tablet dosage form using ethanol as solvent.Methods: The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor (sum of two spectra) and measuring at either the maximum or minimum wavelengths. Then, the method was applied to determine the levels of GUA, DMP, and DPH in tablet dosage form.Results: The application of double divisor ratio spectra derivative spectrophotometry method for the determination of GUA, DMP, and DPH was performed on the first derivative at Δλ 2 (λ 280.0 nm, λ 286.1 nm, and 260.2 nm, respectively). The selection of wavelengths based on wavelengths gives the best result. The mean % recoveries were found to be in 100.60%, 99.95%, and 101.74% for GUA, DMP, and DPH, respectively.Conclusion: The method is successfully applied to analyze GUA, DMP, and DPH in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.

scholarly journals Stability Indicating RP-HPLC Method for the Simultaneous Determination of Atorvastatin Calcium, Metformin Hydrochloride, and Glimepiride in Bulk and Combined Tablet Dosage Form

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Devi Ramesh ◽  
Mohammad Habibuddin
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Atorvastatin Calcium ◽  
Rp Hplc ◽  
Specificity And Sensitivity ◽  
Validation Parameters ◽  
Tablet Dosage

A simple, rapid, and precise RP-HPLC method for simultaneous analysis of atorvastatin calcium, metformin hydrochloride, and glimepiride in bulk and its pharmaceutical formulations has been developed and validated. These drugs were separated by using Grace Smart Altima C-8 column (250 × 4.6 mm, 5-μm) with a mobile phase consisting of acetonitrile : phosphate buffer (60 : 40 (v/v), pH 3.0) at a flow rate of 1 mL/min, injection volume 25 µL, and detection at 235 nm. Metformin, atorvastatin, and glimepiride were eluted with retention times of 2.57 min, 7.06 min, and 9.39 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH (Q2B) guidelines. The results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 10 to 150 µg/mL, 20 to 200 µg/mL, and 10 to 150 µg/mL for atorvastatin, metformin, and glimepiride, respectively. The accuracy and precision were found to be between 98.2%–105% and ≤2% for three drugs. Developed method was successfully applied for the determination of the drugs in tablet dosage form and recovery was found to be >98% for three drugs. The degradation products produced as a result of stress studies did not interfere with drug peaks.

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.

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