scholarly journals Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms

2011 ◽  
Vol 2 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Komal Patel ◽  
Komal Dhudasia ◽  
Amit Patel ◽  
Jayant Dave ◽  
Chaganbhai Patel
Keyword(s):  
Dosage Forms ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Forms ◽  
Stress Degradation ◽  
Degradation Studies

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ENTECAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

2017 ◽  
pp. 107-111
Author(s):  
Swathi P. ◽  
S. Vidyadhara ◽  
R. L. C. Sasidhar ◽  
K. Kalyan Chakravarthi
Keyword(s):  
Flow Rate ◽  
Dosage Forms ◽  
Hplc Method ◽  
Forced Degradation ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Degradation Studies

Objective: The objective and purpose of the analysis have sensibly assessed by selecting of a rapid and sensitive RP-HPLC method for Entecavir in bulk and pharmaceutical dosage form by using the most commonly employed C-18column with UV detection.Methods: In estimation by RP-HPLC method Agilent 1120 compact LC system with variable programmable UV detector and Rheodyne injector with 20 µl fixed loop was used for the chromatographic separation. The mode of operation was isocratic with the components of a solution consisting of methanol: acetonitrile(70:30v/v) and triethanolamine (2-4drops)at the flow rate of 1.2 ml/min and run time was 10 min. Forced degradation studies were conducted to evaluate the stability and specificity of the method along with the validation parameters.Results: Validation parameters of HPLC were found at a detection wavelength of 255 nm. Linearity was observed with the concentration range (Beer’s law range) 20-100µg/ml with R2=0.9991. Robustness with detection wavelengths 253 and 257 nm with a flow rate of 1 ml/min and 1.4 ml/min showed good results. The retention time of the drug was 2.64 min and assay showed 98.1%.Conclusion: The proposed RP-HPLC method was validated as per the ICH Q2B Guidelines, and was found to be applicable for routine quantitative analysis of Entecavir by RP-HPLC using UV detector in pharmaceutical dosage forms. The results of linearity, precision, accuracy and specificity, were proved, that does not exceed certain specified limits. The method provides selective quantification with no interference from other formulation excipients. The proposed method was highly sensitive, reproducible, reliable, robust and specific. Therefore, this method is a simple, rapid analysis may actually be more desirable than a more complicated and time-consuming process. The degradation studies at various stress conditions like thermal and hydrolytic, drug gets degraded at a temperature of 80 °c and refluxing with water at 70 °c for 24hours. 

SIMULTANEOUS ESTIMATION AND VALIDATION OF RAMIPRIL AND TELMISARTAN BY UV SPECTROPHOTOMETRY

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (09) ◽  
pp. 31-35
Author(s):  
R Rambabu ◽  
◽  
S Vidyadhara ◽  
J Subbarao
Keyword(s):  
Spectrophotometric Method ◽  
Correlation Coefficients ◽  
Simultaneous Equation ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Sensitive Spectrophotometric Method

A simple and sensitive spectrophotometric method for the determination of ramipril and telmisartan in pharmaceutical dosage forms has been developed. The absorption maxima were found at 220nm for ramipril and 297nm for telmisartan using 0.1N NaOH as solvent. Beer’s law was obeyed for both the drugs in the concentration range of 2-10μg/ml with correlation coefficients 0.999 for both ramipril and telmisartan. The limits of detection for ramipril and telmisartan were found to be 0.142 and 0.405μg/mL respectively and the limits of quantitation were 0.43 and 1.22μg/mL. Accuracy of the method was verified by performing recovery studies using simultaneous equation method and found to be 98.33 to 99.54%w/w for ramipril and 99.36 to 99.82 %w/w for telmisartan. %RSD of repeatability and intermediate precision studies were found to be <2 for both the drugs. Ruggedness of the method was checked by changing analyst worked and instrument used. In both the cases, the %RSD was found to be less than 2.

scholarly journals DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF LAFUTIDINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (6) ◽  
pp. 75
Author(s):  
Ritesh Kumar ◽  
Amrish Chandra ◽  
Swati Gupta ◽  
Pawan Kumar Gautam
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Ultra Violet ◽  
Dosage Forms ◽  
Uv Absorption ◽  
Uv Spectrophotometry ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms

Objective: The objectives of the present research was to develop a simple, precise, economical, accurate, reproducible and sensitive method for the quantitative estimation of lafutidine in bulk and its pharmaceutical dosage forms by Ultra Violet (UV) absorption spectrophotometry.Methods: The method uses 0.1 N HCl, pH 1.20 as a solvent of choice for the quantitative estimation of lafutidine in bulk and its tablets dosage form by UV absorption spectrophotometry at a wavelength of 290 nm. The method was validated for parameters like linearity, range, precision, Limit of Detection (LOD), Limit of Quantification (LOQ), accuracy, recovery and stability of the analyte.Results: Lafutidine exhibited absorbance maxima at 290 nm in 0.1 N HCl, pH 1.20 solvent. The developed method was validated as per the ICH validation guidelines. Beer’s law was obeyed in range of 0-30 µg/ml with r2= 0.9997. The LOD and LOQ values of lafutidine were found to be 0.545 µg/ml and 1.654 µg/ml respectively. The mean % recovery for the developed method was found to be in the range of 99.25 to 99.45 % respectively for the marketed dosage forms. The developed method was also found to be robust.Conclusion: The developed method was found suitable for the routine quantitative analysis of lafutidinein bulk and pharmaceutical dosage form. It was also concluded that developed UV spectrophotometry method was accurate, precise, linear, reproducible, robust and sensitive.

DEVELOPMENT AND VALIDATION OF AN IMPROVED STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF TROXIPIDE IN BULK AND TABLET DOSAGE FORMS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (07) ◽  
pp. 18-22
Author(s):  
D. Gowrisankar ◽  
◽  
N.M Rao
Keyword(s):  
Degradation Products ◽  
Thermal Conditions ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Improved Stability ◽  
Degradation Studies ◽  
Tablet Dosage

An improved stability-indicating RP-HPLC method was developed for the estimation of troxipide in bulk and tablet dosage forms. Chromatographic separation of troxipide from its degradation products was achieved on Agilent Zorbax SB-CN (150 × 4.6 mm, 3.5 μm) using sodium phosphate buffer (pH was adjusted to 4.0 ±0.05) and acetonitrile in the ratio of 40:60 V/V, at a flow rate of 0.8 mL/min. This system was found to give compact peak for troxipide at 2.1±0.2 min. The detection was monitored at 260 nm. The linear regression data for the calibration plots showed good relationship with r2 = 0.99 ± 0.001. The method was validated for precision, linearity, accuracy and robustness according to International Conference on Harmonization (ICH) guidelines. The percentage RSD was found to be less than two, indicating high degree of accuracy and precision of the proposed RP-HPLC method. The drug was subjected to stress degradation studies under acidic, basic, oxidative and thermal conditions. The degradation studies reveal that purity angle was less than the purity threshold, so the peak was said to be pure. It means that products resulting from stress studies did not interfere with the detection of troxipide and the assay can thus be considered as stability-indicating. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining troxipide in bulk and in pharmaceutical dosage forms.

scholarly journals The metrological parameters of diosmin quantitation in pharmaceutical dosage forms

2020 ◽  
Vol 20 (5-6) ◽  
pp. 151-156
Author(s):  
Alexander V. Voronin ◽  
Maksim N. Kachalkin ◽  
Alexander V. Karpov
Keyword(s):  
Quality Control ◽  
Sample Preparation ◽  
Sodium Hydroxide Solution ◽  
Dosage Forms ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Forms ◽  
Drug Quality ◽  
Specific Absorbance ◽  
Metrological Parameters ◽  
Drug Quality Control

Introduction. Pharmaceutical dosage forms with diosmin are allowed for medical use in Russian Federation. Simple and informative methods of diosmin quantitation for drug quality control are needed. Aim: determination of metrological parameters of diosmin quantitation in pharmaceutical dosage forms by UV-spectrophotometry. Matherials and methods. The study subjects Venarus, Detralex (tablets, suspension), Phlebopha. Diosmin were quantified by UV-spectrophotometry. The reference-specific absorbance values of diosmin at wavelengths of 268 and 370 nm by the parameters of calibration were determined. Statistical data processing was carried out by the methods of variation statistics, correlation, one-way analysis of variance using computer programs ChemMetr 1.0, ChemMetr Evaluation 1.0, Statistica 6.0 (Statsoft Inc., USA). Results. The range of diosmin quantitation by UV-spectrophotometry was revealed for the wavelength of 268 nm 0,0001-0,001%, 370 nm 0,0002-0,002%. The reference-specific absorbance values for diosmin at the wavelength of 268 and 370 nm in a sodium hydroxide solution 0,02M were 463,0 24,6 and 259,0 9,9 respectively. The mean errors of diosmin concentrations in pharmaceutical dosage forms were revealed for the wavelength of 268 nm 8-12% and for 370 nm 6-8%. Prognostic calculation of the sample preparation error (extraction) for diosmin was performed using the example of Detralex tablets. The sample preparation error was 8%. Conclusion. The values components of error for reference-specific absorbance value and sample preparation error for diosmin quantitation were determined (as exemplified by the study of Detralex tablets). Calculation algorithms can be used for error estimation of sample preparation for other multicomponent samples in drug quality control.

scholarly journals Method developed for the determination of apixaban by using U.V. spectrophotometric

2019 ◽  
Vol 1 (3) ◽  
pp. 83-87
Author(s):  
B. Mahendra ◽  
K. Harika Sundari ◽  
T. Vimalakkannan
Keyword(s):  
Spectrophotometric Method ◽  
Cost Effective ◽  
Dosage Forms ◽  
Routine Analysis ◽  
Uv Spectrophotometry ◽  
Pharmaceutical Dosage Forms

The present work is aim to Develop UV spectrophotometry method for the estimation of Apixaban in its dosage forms. Analysed the marketed formulations for their reliability and accuracy and Performed the recovery studies for the developed UV spectrophotometric method. The developed method was validate for its accuracy precision reproducibility. On the basis of results the UV spectrophotometric method developed for the determination of Apixaban is found to be precise, accurate and cost effective. Hence this method can be used for routine analysis of Apixaban in bulk and pharmaceutical dosage forms.

scholarly journals Spectrophotometric determination of chlorpheniramine maleate and phenylpropanolamine hydrochloride in dosage forms

2013 ◽  
Vol 2 (5) ◽  
pp. 97-100 ◽  
Author(s):  
Arun Kaura ◽  
Vikas Gupta ◽  
G S Roy ◽  
Monika Kaura
Keyword(s):  
Pharmaceutical Journal ◽  
Dosage Forms ◽  
Uv Spectrophotometry ◽  
Chlorpheniramine Maleate ◽  
Simple Method ◽  
Pharmaceutical Dosage Forms ◽  
First Derivative ◽  
Phenylpropanolamine Hydrochloride ◽  
Derivative Uv Spectrophotometry

A rapid and simple method for simultaneous determination of Chlorpheniramine Maleate (CPM) and Phenylpropanolamine Hydrochloride (PPM) by first derivative UV spectrophotometry has been developed in combined pharmaceutical dosage forms. The proposed method was successfully applied for the determination of drugs in physical mixture and commercial formulations and results showed good linearity, precision and reproducibility. DOI: http://dx.doi.org/10.3329/icpj.v2i5.14436 International Current Pharmaceutical Journal, April 2013, 2(5): 97-100 

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