scholarly journals Simultaneously Content Analysis of Sulfadoxine and Pyrimethamine in Tablet Dosage Form by Spectrophotometry Ultraviolet with Dual Wavelenght Method

2019 ◽  
Vol 7 (4) ◽  
pp. 34-37
Author(s):  
Andry Muhammad ◽  
De Lux Effendy ◽  
Putra Muchlisyam
Keyword(s):  
Content Analysis ◽  
Single Dose ◽  
Dosage Form ◽  
Method Development ◽  
Aim Method ◽  
Validation Parameters ◽  
Multiple Wavelengths ◽  
Tablet Dosage ◽  
Sulfonamide Group

Aim: method development results from this study are expected to be one of the methods that can be applied by the relevant agencies in determining the simultaneous levels of sulfadoxine and pyrimethamine in tablet dosage form. Pyrimethamine - Sulfadoxine (PS) is an anti-malarial drug combination sulfonamide group / sulfone with nature skizontosida diaminopirimidine network, these drugs are very practical because it can be given in a single dose, and however, this combination provides a new challenge for the pharmaceutical industry in connection with the development of new analytical methods in the determination of levels. Methods: The study was carried out experimentally by spectrophotometric method is the method of multiple wavelengths and then tested for validity based validation parameters, namely linearity, accuracy, precision, LOD and LOQ and intraday and inter day. Then, the method is tested on dosage tablets containing pyrimethamine and sulfadoxine that are on the market. Results: The results showed that the application of the method of multiple wavelengths at a concentration carried out at λ 284.8 nm and 258.8 nm to pyrimethamine and at λ 274.2 nm and 291.6 nm to sulfadoxine. Research results successfully applied the method dual wavelength which is successfully applied to determining the concentration of pyrimethamine and sulfadoxine simultaneously in a tablet.    

HPLC METHOD DEVELOPMENT FOR ESTIMATION OF RAMELTEON IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 20-23
Author(s):  
S Sahoo ◽  
◽  
P. K. Panda ◽  
S. K. Mishra
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Tablet Dosage ◽  
Good Agreement

A simple, fast, accurate and precise reverse phase HPLC method is developed and described for the determination of ramelteon in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 7.0 (35:65 V/V) as the mobile phase at a flow rate of 1.0 mL/min with detection at 286 nm. The retention time of the drug was 7.7 min. The procedure was validated for linearity, precision, accuracy, and robustness. The developed method was validated for linearity from 50 to 150% which shows the method is quite linear with a correlation coefficient of 0.999, for precision which includes system precision, method precision, intraday and by another analyst on another day, and accuracy. The %RSD for system precision was observed to be 1.1, whereas the method precision was observed to be 0.2. The % recovery from ‘accuracy’ studies yielded the recovery of 99.7-101.5% which indicates the capability of the method, and finally for robustness that includes studies w.r.t. change in flow rate, the percentage of organic modifier and pH. As per ICH guidelines, method validation results are in good agreement. The proposed method was simple, sensitive, precise and accurate.

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 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.

Analytical Method Development and Validation for Simultaneous Estimation of Trimetazidine Hydrochloride and Metoprolol Succinate Using HPTLC

2019 ◽  
Vol 15 (3) ◽  
pp. 243-250 ◽  
Author(s):  
Surendra Agrawal ◽  
Pravina Gurjar ◽  
Bhavik Katheriya
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Simultaneous Estimation ◽  
Metoprolol Succinate ◽  
Limit Of Quantitation ◽  
Label Claim ◽  
Tablet Dosage ◽  
Hptlc Method

Introduction: Trimetazidine and Metoprolol combination is more effective in the treatment of cardiac disorders as compared to single drug therapy.Background: Materials and Methods: A rapid, simple, and sensitive HPTLC method was developed for the simultaneous determination of Trimetazidine and metoprolol from its tablet dosage form and validated. In HPTLC method, standard and sample solutions of Trimetazidine hydrochloride and metoprolol succinate were applied on pre-coated silica gel G 60 F254 TLC plate, and developed by using mobile phase, n-butanol :water: methanol: ammonia as solvent (8.5:0.1:0.1: 0.85, v/v). The drugs on plate were scanned at 213 nm. The method produced compact and well-resolved bands at Rf of 0.32 ± 0.02 and 0.66 ± 0.02 for Trimetazidine Hydrochloride and Metoprolol succinate respectively. The range for linearity was observed as 500-2500 ng band-1 for Trimetazidine hydrochloride and 500-2500 ng band-1 for metoprolol succinate and correlation coefficient were 0.9991 and 0.9997 respectively. Conclusion: The developed method was validated according to the ICH guidelines for precision, accuracy, Limit of detection, Limit of quantitation, specificity and robustness. The method was checked for suitability in determination of Trimetazidine hydrochloride and Metoprolol succinate in their tablet dosage form. The assay result was found to be 99.64 % ± 0.45 and 99.94 % ± 0.53 of percentage label claim for Trimetazidine hydrochloride and Metoprolol succinate respectively.

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

Analytical Method Development and Validation for Telmisartan, Chlorthalidone and Amlodipine by UV- Spectroscopic Method.

2021 ◽  
pp. 6049-6054
Author(s):  
Rutuja M. Sanap ◽  
Sarika R. Wavhale ◽  
Vaibhavi V. Kunjir ◽  
Rajkumar V. Shete
Keyword(s):  
Simultaneous Determination ◽  
Analytical Method ◽  
Dosage Form ◽  
Method Development ◽  
Correction Method ◽  
Absorption Correction ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, sensitive and accurate UV- spectrophotometric absorption correction method has been developed for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form. Analytical method development and validation plays important role in the discovery manufacture of pharmaceuticals and development. In this paper, absorption correction method is used for multi-component analysis. The wavelengths selected for the analysis were 311nm for Telmisartan, 228nm for Chlorthalidone and 253nm for Amlodipine. Beer’s law obeyed the concentration range of 2-10 µg /ml, 2-10 µg /ml and 5-25 µg/ ml for Telmisartan, Amlodipine and Chlorthalidone. Methanol is used as a solvent. The accuracy of the method was assessed by recovery studies and was found between the range of 100% to 110% for Telmisartan, 85% to 110% for Amlodipine and 85% to 105% Chlorthalidone. The % RSD value was found to be less than 2. Thus, the method was simple, precise, economic, rapid, accurate and can be successfully applied for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form.

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 DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PSEUDOEPHEDRINE HYDROCHLORIDE IN TABLET DOSAGE FORM

2020 ◽  
pp. 249-252
Author(s):  
RIDA EVALINA TARIGAN ◽  
MUCHLISYAM ◽  
SITI MORIN SINAGA ◽  
ZUL ALFIAN
Keyword(s):  
Ternary Mixture ◽  
Dosage Form ◽  
Acceptable Range ◽  
Validation Parameters ◽  
Recovery Study ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Dextromethorphan Hydrobromide

This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of dextromethorphan hydrobromide (DEX), doxylamine succinate (DOX) and pseudoephedrine hydrochloride (PSE) in tablet dosage form using ethanol as solvent. The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor and measuring at the wavelengths selected. Then, the method was applied to determine the levels of DEX, DOX and PSE in tablet dosage form. The selected wavelengths for determination of DEX, DOX and PSE are 277.0 nm, 243.0 nm, and 243.2 nm, respectively. The mean % recoveries were found to be in 100.88%, 100.05%, and 100.26% for DEX, DOX and PSE, respectively. The method is successfully applied to analyze DEX, DOX and PSE in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.

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