scholarly journals Analytical Method Development and Validation for Estimation of Mifepristone in Pure and Pharmaceutical Dosage Form

2021 ◽  
pp. 120-130
Author(s):  
Sheetal Bastia ◽  
Vaibhav Gawade ◽  
Vitthal Chopade ◽  
Rahul Jagtap ◽  
Vishal Modi
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
High Degree ◽  
Tablet Dosage

Mifepristone structurally belongs to the class of anti-progesterone steroids, which are used as an oral contraceptive. The reverse phase HPLC method was designed in a simplified and rapid way for the estimation of Mifepristone in bulk as well as tablets. The method was established using a Kromasil C18 column of dimensions of 250mm×4.6mm and a particle size of 5m.The used mobile phase was Acetonitrile: Water (70:30, v/v). The pump was pumped at 1 ml/min at a temperature of about 30 ± 2 °C and the eluted analyte was identified at 305 nm. Mifepristone eluted with a mean retention time of 6.27 minutes. The intended method was validated as per ICH (International Council for Harmonisation) guidelines, indicating a high degree of specificity, system suitability, accuracy, precision, and robustness. The LOD (Limit of detection) was found to be 0.7238 ppm and the limit of measurement was 0.9562 ppm. The method linearity was found to be between 1-6µg/ml, with an R2 of 0.9923. In accuracy studies, the percent recovery was found to be between 99.39% - 100.50%. The method was discovered to be precise as the values of the percent RSD were found to be less than 2.0% for both intraday and interday. The method was discovered to be reliable and robust. Mifepristone in marketed pharmaceutical tablet dosage form was effectively quantified using the established Reverse Phase HPLC method.

scholarly journals Development and Validation of Reverse Phase HPLC Method for Simultaneous Estimation of Allopurinol and Lesinurad in its API and Pharmaceutical Dosage Form

2019 ◽  
Vol 4 (04) ◽  
pp. 50-57
Author(s):  
Sayma Khader ◽  
Ayesha Begum K ◽  
D. Ramakrishna
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage

A new, reliable, and validated reverse phase-high-performance liquid chromatography (HPLC) method was developed to quantify the amount of allopurinol and lesinurad simultaneously in solid (tablet) dosage form. A clear chromatographic division was attained on inertsil ODS (4.6 x 250 mm, 5 mm) column, and a mixture of 0.1% trifluoroacetic acid and methanol in the ratio of 40:60 v/v was used as mobile phase. The rate of flow was set at 1 mL/min, and UV detection was achieved at λmax of 255 nm. Injection volume was set to 20 μL. The correlation coefficient of 0.999 was established, and the accurateness was found to be 100.69 and 100.49 for both the drugs, respectively. Therefore, the developed method was simple, specific, precise, and stable. Hence, the method can be employed to estimate the said drugs in other pharmaceutical formulations.

Method Development and Validation of Spectrophotometric Methods for The Estimation of Rizatriptan Benzoate in Pure and Pharmaceutical Dosage Form

2021 ◽  
pp. 6003-6006
Author(s):  
Pushpa Latha E. ◽  
Sailaja B.
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rizatriptan Benzoate ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Analytical UV derivative spectrophotometric method was developed and validated to quantify Rizatriptan Benzoate in pure drug and tablet dosage form. Based on the spectrophotometric characteristics of Rizatriptan Benzoate, a signal of zero (225nm), first (216nm), second (237nm), third (233nm), fourth (231nm) order derivative spectra were found to be adequate for quantification. The methods obeyed Beer's law in the concentration range of (0.1-360µg/ml) with square correlation coefficient (r2) of 0.999. The mean percentage recovery was found to be 100.01 ± 0.075. As per ICH guidelines the results of the analysis were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and were found to be satisfactory.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of Grazoprevir and Elbasvir in bulk and pharmaceutical dosage form

2018 ◽  
Vol 1 (1) ◽  
pp. 1-7
Author(s):  
V. Pavan Kumar ◽  
A. Vijaya Kumar ◽  
B Sivagami ◽  
R. Charan Kumar ◽  
M. Niranjan Babu
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Potassium Hydrogen ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate and precise method was developed for the simultaneous estimation of the Grazoprevir and Elbasvir in Tablet dosage form. Chromatogram was run through Kromosil C18 (250 x 4.6 mm), 5m. Mobile phase containing Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was Di Potassium Hydrogen ortho Phosphate. Temperature was maintained at 30°C. Optimized wavelength selected was 215 nm. Retention time of Elbasvir and Grazoprevir and were found to be 2.503 min and 3.004. %RSD of the Elbasvir and Grazoprevir were and found to be 0.3 and 0.4 respectively. %Recovery was obtained as 98.17% and 99.83% for Grazoprevir and Elbasvir respectively. LOD, LOQ values obtained from regression equations of Grazoprevir and Elbasvir were 0.24, 0.73 and 0.06, 0.19 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

scholarly journals Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

2021 ◽  
pp. 254-271
Author(s):  
Sayyed Nazifa Sabir Ali ◽  
Lajporiya Mobina ◽  
Manjra Mehfuza ◽  
Patel Seema ◽  
Aejaz Ahmed ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Forced Degradation ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation

Aims: To develop and validate a new, simple, rapid, precise, and accurate An Eco-friendly RP-HPLC and UV-Method Development and Validation for an estimation of Favipiravir in Bulk and pharmaceutical dosage form followed by Forced Degradation Studies. Study Design: This was employed for UV-visible (200-400 nm and 400-800 nm respectively) and RP-HPLC method development using C 18 inertsil column and optimization of variables for Favipiravir estimation in bulk and formulations. Place and Duration of the Study: The present work was carried out at Ali-allana College of Pharmacy, Akkalkuwa between the duration of November-2020 to February-2021. Methodology: UV-Spectroscopic method was developed for the estimation of Favipiravir in the bulk and pharmaceutical dosage form. The solvent selected for the Favipiravir UV analysis was water, the solution in a range of 2-10µg/ml was scanned in the UV region from 200-400 nm and the λmax value was determined. The RP-HPLC method was developed on inertsil ODS-3V C18 150 mm x 4.6mm x 5μ column using buffer pH 3.5: acetonitrile [90:10] as mobile phase at flow rate 1.0 ml/min and PDA detection at 358 nm. Results: The maximum absorbance was observed at 358 nm. The wavelength 358 nm was selected for further analysis of Favipiravir. The calibration curve was determined using drug concentrations ranging from 2-10 µg/ml. The % recovery for accuracy was 100.50-100.76%. The method was to be precise with a % RSD value 0.51-1.37 and 0.77-1.78 for intraday and Interday respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0723 &0.219 µg/ml respectively by UV method. The RP-HPLC method was shown to be linear in the 50-250 μg/ml concentration range. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 2.186 & 6.626 μg/ml respectively. The method was to be precise with a % RSD value 0.25-1.53 and 0.86-1.68 for intraday and inter-day respectively. Conclusion: Here we conclude that the developed UV and RP-HPLC methods are precise, accurate, sensitive, and reproducible for the quantitative estimation of Favipiravir bulk and its formulation. The developed method can be used by the pharmaceutical industries for the routine analysis of Favipiravir, in particular by UV and RP-HPLC. The main features of the proposed method are economic and eco-friendly with less retention time around 5.0 min.

scholarly journals Analytical Method Development and Validation for Estimation of Silymarin in Tablet Dosage form by HPLC

2020 ◽  
pp. 22-31
Author(s):  
Sneha Singh ◽  
Mohit Saini ◽  
Jitender K. Malik ◽  
Amit Kumar
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Low Cost ◽  
Pharmaceutical Preparations ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Silymarin is extracted from the Silybum marianum (milk thistle) plant C25 containing flavonoid mixture. It is mainly used for its effect in liver disease. The HPLC of silymarin tablet had been validated for precision, accuracy (recovery), selectivity & Linearity. In the present study, an attempt was made to provide a newer, simple, sensitive, precise and low cost HPLC method for the effective quantitative determination of silymarin as an active pharmaceutical ingredient as well as in pharmaceutical preparations without the interferences of other constituent in the formulations. HPLC method is developed and validated for various parameters as per ICH guidelines. The validated method was effectively useful to the commercially accessible pharmaceutical dosage form, yielding extremely good and reproducible result.

scholarly journals New Analytical Method Development and Validation for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method

2020 ◽  
Vol 10 (5) ◽  
pp. 143-148
Author(s):  
T. Hanuman ◽  
T. Sivakkumar ◽  
S. Sridhar
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sofosbuvir and Velpatasvirin pharmaceutical dosage form. The column used was Kromosil C18(150mm x 4.6 mm, 5mm)in isocratic mode, with mobile phase containing phosphate buffer andacetonitrile(70:30v/v). The buffer is prepared by adding 1.41gm of sodium dihyrogen ortho phosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 3.5 with dil. orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260 nm. The retention times of Sofosbuvir and Velpatasvirwere found to be 2.404min and 2.986 min, respectively. The linearity for Sofosbuvir and Velpatasvirwere in the range of 40-240µg/ml and 10-60 µg/ml respectively. The recoveries of Sofosbuvir and Velpatasvirwere found to be 99.64% and 99.25%, respectively. The proposed method was validated and successfully applied to the estimation of Sofosbuvir and Velpatasvirin combined tablet dosage forms. Keywords: Sofosbuvir, Velpatasvir, Validation, Buffer and ICH Guidelines.

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