scholarly journals Development and validation of stability indicating UPLC method for the estimation of ticagrelor in bulk and its tablet dosage form

2019 ◽  
Vol 9 (1-s) ◽  
pp. 201-205
Author(s):  
J Omaima ◽  
, Shyamala ◽  
J V C Sharma
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Regression Equations ◽  
Injection Volume ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

The objective of the method was to develop a simple, rapid, sensitive, precise, accurate and validated Ultra Performance Liquid Chromatographic (UPLC) method for the estimation of Ticagrelor in tablet dosage form. Chromatographic separation was achieved on an acquity UPLC BDS C8 (150 x 4.6 mm, 5m) column with a mobile phase composed of Buffer 0.1% OPA (2.2 pH) and  Acetonitrile  in the ratio of 60:40   at a flow rate of 1.0 ml/min and 1 μl injection volume. The effluents were detected at a wavelength of 240 nm using TUV detector. The retention time of Ticagrelor was  found to be at 0.942 min. %RSD of the Ticagrelor was found to be 0.7  The method was validated with respect to specificity, accuracy, linearity, precision, robustness. The correlation coefficient for Ticagrelor was found to be 0.999. Recovery of Ticagrelor in formulation was found to be 99.51% . LOD, LOQ values obtained from regression equations of Ticagrelor were 0.45, 1.35 respectively.  Due to simplicity, high precision and rapidness the method can be successfully applied for   estimation of Ticagrelor in tablet dosage form. Keywords: Ultra Performance Liquid Chromatographic, Ticagrelor, Tablet dosage form.

scholarly journals Development and Validation of RP-HPLC for Estimation of Neratinib in Bulk and Tablet Dosage Form

2019 ◽  
Vol 11 (02) ◽  
Author(s):  
M Lakshmi Kanth ◽  
B Raj Kama
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Chromatographic Separation ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Rp Hplc ◽  
Monopotassium Phosphate ◽  
Development And Validation ◽  
Tablet Dosage

An accurate RP-HPLC method developed for the estimation of Neratinib in bulk and tablet dosage form. The method is and validated for parameters linearity, accuracy, suitability, specificity, precession, LOD, LOQ and robustness. An Altima column (150 mm × 4.6 mm × 5μ) used for chromatographic separation within a runtime of 6 min. The mobile phase buffer (monopotassium phosphate) and acetonitrile (60:40 v/v) with 0.1% formic acid is used. The flow rate maintained at 1.0 ml/min with the effluents monitored at 215 nm. The Neratinib analyzed at retention time of 4.001. The concentration linear over 30-180μg/ml with regression equation y = 6065.6x + 795.43 and regression co-efficient 0.999.

scholarly journals Development and Validation of New Analytical Method for The Simultaneous Estimation of Levodropropizine And Chlorpheniramine In Pharmaceutical Dosage Form

2021 ◽  
pp. 33-42
Author(s):  
Vepa Vishnu Vardhan Reddy ◽  
P.Sreenivasa Prasanna ◽  
K. Thejomoorthy
Keyword(s):  
Quality Control ◽  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate, precise method was developed for the simultaneous estimation of the Levodropropizine and Chlorpheniramine in Tablet dosage form. The chromatogram was run through Ascentis C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer Kh2po4: Acetonitrile was taken in the ratio 40:60was pumped through the column at a flow rate of 1.0ml/min. The buffer used in this method was Kh2po4. The temperature was maintained at 30°C. The optimized wavelength selected was260nm. The retention time of Levodropropizine and Chlorpheniramine was found to be 2.276min and 2.848. %RSD of the Levodropropizine and Chlorpheniramine was and found to be 0.7 and 0.7 respectively. %Recovery was obtained as 100.73% and 99.03% for Levodropropizine and Chlorpheniramine respectively. LOD, LOQ values obtained from regression equations of Levodropropizine and Chlorpheniramine were 0.14, 0.02, and 0.43, 0.06 respectively. Regression equation of Levodropropizine is y = 67089x + 5956.8 and y = 226526x + 13941 of Chlorpheniramine. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.  

scholarly journals Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form

2021 ◽  
pp. 49-57
Author(s):  
Pemra Raju ◽  
K. Thejomoorthy ◽  
P.Sreenivasa Prasanna
Keyword(s):  
Quality Control ◽  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate, precise method was developed for the simultaneous estimation of the Darunavir and Ritonavir in Tablet dosage form. The chromatogram was run through Agilent C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% Formic acid: Acetonitrile, taken in the ratio 70:30 was pumped through the column at a flow rate of 0.95 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 293 nm. The retention times of Darunavir and Ritonavir were found to be 2.369min and 2.911. %RSD of the Darunavir and Ritonavir were and found to be 0.7 and 0.5 respectively. %Recovery was obtained as 99.67% and 99.78% for Darunavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Darunavir and Ritonavir were 1.49, 5.191and 0.37, 1.11 respectively. Regression equation of Darunavir is y = 5421x + 640.7, and y = 3870.x + 5191 of Ritonavir. 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 tests in Industries.

scholarly journals Development and Validation of New Analytical Method for The Simultaneous Estimation of Netupitant And Palonosetron In Pharmaceutical Dosage Form

2021 ◽  
pp. 50-59
Author(s):  
Potluri Surendra ◽  
P.Sreenivasa Prasanna ◽  
K. Thejomoorthy
Keyword(s):  
Quality Control ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation

A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in Pharmaceutical dosage form. The chromatogram was run through Std Discovery C18250 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA (2.2ph): Acetonitrile taken in the ratio 55:45 was pumped through the column at a flow rate of 1 ml/min. The buffer used in this method was 0.1% OPA. The temperature was maintained at 30°C. The optimized wavelength selected was 220 nm. The retention time of Netupitant and Palonosetron was found to be 2.308min and 3.093min. %RSD of the Netupitant and Palonosetron were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 99.51% and 99.29% for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.84, 0.01, and 5.59, 0.03 respectively. Regression equation of Netupitant  is y = 7232.8x + 3439.3., and y = 28857x + 97.732 of Palonosetron. 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 tests in Industries.

scholarly journals Analytical method development and validation of assay test of pravastatin sodium tablets

2019 ◽  
Vol 9 (2) ◽  
pp. 70-75
Author(s):  
Ashvini C Shinde ◽  
Nitin V Devhadrao ◽  
Ashwini S Bansode ◽  
Ajit S Bansode
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Solution Stability ◽  
Pravastatin Sodium ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise and stability indicating Ultra performance liquid chromatographic method for determination of pravastatin sodium in tablet dosage form. The separation was carried on Acquity UPLC ® HSS C18, 2.1 × 100mm, 1.8µm ID column, with mobile phase comprising of mixture of pH 5.5 buffer: methanol in the ratio of 30 : 70 v/v, as the mobile phase at a flow rate  0.2 ml/min and the detection was carried out using UV-visible detector at 238nm. The method was validated by evaluation of different parameters such as accuracy, precision, linearity, ruggedness, robustness, filter equivalency, solution stability. The retention time were found to be 1.5 min. Calibration curves were linear with correlation coefficient (r2) 0.999. The Percent assay of Pravastatin sodium tablet was found to be 98.4%. The developed methods were validated as per the ICH guidelines. Keywords: Pravastatin sodium (PVS), UPLC, Method Validation.

FORCED INDICATING UPLC-DAD METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF APALUTAMIDE IN BULK AND IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (09) ◽  
pp. 73-75
Author(s):  
China Babu D ◽  
Madhusudhana Chetty C ◽  
Mastanamma S. K ◽  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Uv Light ◽  
Accurate Method ◽  
Pharmaceutical Dosage Form ◽  
Good Ability ◽  
Acquity Uplc ◽  
Development And Validation

A new analytical method was developed for the estimation of apalutamide in bulk and its pharmaceutical formulation. The sensitive, précise and accurate method was developed by using Waters Acquity UPLC system equipped with quaternary gradient pump. The column used was Waters C18 150 X 2.1 mm X 1.7 µm and mobile phase was 0.2 % OPA buffer in water : acetonitrile in the ratio of 25:75 V/V. The buffer pH was maintained at 4.5. The fl ow rate of mobile phase was 0.5 mL min-1 and detection was at 272 nm by using PDA detector. The method was performed at ambient temperature. The retention time of the apalutamide was 1.27 min. The % RSD value in precision was >2 %. The accuracy of the method was found to be between 99.54 % - 100.01 %. The limit of detection and limit of quantifi cation values were found to be 0.14 µg mL-1 and 0.48 µg mL-1, respectively. The linearity concentration range was found to be 11.25 - 67.5 µg mL-1, it show wide linearity concentration range. The method was proved to have good robustness after changing parameters of fl ow rate, temperature and mobile phase composition. The method showed good ability towards different stress conditions of acidity, alkalinity, peroxide and UV-light. The method can be used for the routine analysis of apalutamide in bulk and its pharmaceutical dosage form by using UPLC.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Correlation Coefficients ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of abacavir sulphate (ABA) and lamivudine (LAM) in combined dosage form. Separation was performed on a C18 column [Agilent ODS UG 5 column, 250 mm x 4.5 mm], with methanol: water (50:50 V/V) isocratic elution using a flow rate of 1mL/min. Good sensitivity was observed with UV detection at 277 nm. After method development, the interference of other active compounds and excipients, repeatability and linearity, were investigated. Retention times of LAM and ABA were found to be 3.3 and 6.3 min, respectively. The method was validated over the range from 2.5-12.5 μg/mL for LAM and 5-25 μg/mL for ABA with correlation coefficients of 0.9997 and 0.9996, respectively. This method was shown to be accurate, robust, selective, linear, and repeatable and can be successfully employed in routine quality control for the simultaneous analysis of ABA and LAM in tablets.

scholarly journals Development and validation of new analytical method for the simultaneous estimation of daunorubicin and cytarabine in bulk and pharmaceutical dosage form

2021 ◽  
pp. 32-39
Author(s):  
Kankipati Benjimen ◽  
K. Thejomoorthy ◽  
P.Sreenivasa Prasanna
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Control Test ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Daunorubicin and Cytarabine inhalation dosage form. Chromatogram was run through BDS C18 150 x 4.6 mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 240nm. Retention time of Daunorubicin and Cytarabine were found to be 2.245 min and 2.813. %RSD of the Daunorubicin and Cytarabine were and found to be 0.6and 0.3 respectively. %Recovery was obtained as 99.39% and 99.26% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equations of Daunorubicin and Cytarabine were 0.03, 0.10 and 0.31, 0.94 respectively. Regression equation of Daunorubicin is y = 2677x + 703.5, y = 2524x + 104.7 of Cytarabine.Retention times were decreased and that 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 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.

Development and Validation of Stability Indicating UPLC Method for Simultaneous Estimation of Phenylephrine and Fexofenadine in Suspension Dosage Form

2020 ◽  
Vol 13 (5) ◽  
pp. 5069-5074
Author(s):  
Rajitha G ◽  
Geetha Susmita Adepu
Keyword(s):  
Quality Control ◽  
Dosage Form ◽  
Orthophosphoric Acid ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Relative Standard ◽  
Pharmaceutical Industries ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Liquid Chromatographic

Phenylephrine and fexofenadine are widely used products for common cold and allergic conditions. In this study, a simple, reliable, sensitive and economical Ultra Performance Liquid Chromatographic (UPLC) method was developed and validated for the simultaneous estimation of phenylephrine and fexofenadine in suspension dosage form. Efficient chromatographic separation was achieved on Acquity UPLC HSS C18 x 1.8μm column with mobile phase consisting of orthophosphoric acid buffer (pH = 2.8) and acetonitrile (55:45% v/v) at a flow rate of 0.3ml.min-1 and 1μl injection volume. TUV detector was used and detection wavelength was 272nm. The retention times of phenylephrine and fexofenadine were found to be 1.347 and 1.536 ± 0.01 mins respectively. The percentage recoveries of phenylephrine and fexofenadine were 99.93% and 99.31% respectively. The relative standard deviation for assay was found to be <2. The detection and quantification limits were found to be 0.04 and 0.13μg/ml for phenylephrine and 0.21 and 0.65μg/ml for fexofenadine respectively. Thus, the developed UPLC method was simple, rapid, sensitive and economical and it can be applied for the routine quality control analysis of combined dosage forms in quality control laboratories and in pharmaceutical industries.

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