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 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 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 Development and validation of new analytical method for the simultaneous estimation of Netupitant and Palonosetron in bulk and pharmaceutical dosage form

2021 ◽  
pp. 27-35
Author(s):  
Pushpa Divya P ◽  
Raj Kumar kudari
Keyword(s):  
Quality Control ◽  
Retention Time ◽  
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 Netupitant and Palonosetron in pharmaceutical dosage form. Retention time of Palonosetron and Netupitant were found to be 2.266 min and 2.805 min. %RSD of the Netupitant and Palonosetron were and found to be 0.8 and 1.1 respectively. %Recovery was obtained as 100.08% and 100.15% for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.63, 4.94 and 0.003, 0.010. respectively. Regression equation of Netupitant is y =11553x + 9661.and y = 51072x + 152.0. of Palonosetron. 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 Simultaneous estimation of gabapentin and methylcobalamin in bulk and pharmaceutical dosage form by RP-HPLC

2019 ◽  
Vol 9 (1) ◽  
pp. 170-174
Author(s):  
Anjali Bakshi ◽  
K Monika ◽  
Shweta Bhutada ◽  
M. Bhagvan Raju
Keyword(s):  
Particle Size ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Methylcobalamin from bulk and formulation. Chromatographic separation was achieved Isocratically on an Inertsil C18 column (150x4.6, 5µ particle size) using a mobile phase Buffer: Acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, effluents were detected at 264 nm and 10µl of sample was injected. Retention time of Gabapentin & Methylcobalamin was found to be 2.7 and 4.13 min respectively. Linearity of the method was in the concentration range of 25-150 µg for Gabapentin & 0.125-0.750 µg for Methylcobalamin. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision of the method was found to be less than 2%. The method was validated according to the ICH guidelines. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin & Methylcobalamin tablets and was fairly good in comparison with other methods. Keywords: Gabapentin, Methylcobalamin, HPLC.

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 a Rapid Chemometrics Assisted RP-HPLC with PDA Detection Method for the Simultaneous Estimation of Pyridoxine HCl and Doxylamine Succinate in Bulk and Pharmaceutical Dosage Form

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
P. Giriraj ◽  
T. Sivakkumar
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Optimization Procedure ◽  
System Response ◽  
Simultaneous Estimation ◽  
Mobile Phase Flow Rate ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

Simple, rapid, precise, and accurate RP-HPLC method was developed and optimized with the help of chemometric tool for the simultaneous estimation of pyridoxine HCl and doxylamine succinate in bulk and pharmaceutical dosage form. Optimization was done by central composite design in response surface methodology. Based on the trial and error, percentage of organic phase (methanol) in mobile phase, flow rate, and molarity of the buffer were selected as factors. Resolution and retention time were used for the estimation of system response during the optimization procedure. The optimized condition was used and the separation was carried out on phenomenex C18 column (150 × 4.6 mm; i.d, 5 μ particle size) using the mobile phase containing 49.37% of methanol and 50.63% of phosphate buffer (45.14 mM) at a flow rate of 1 mL/min. Retention time was found to be 1.884 minutes for pyridoxine HCl and 3.959 minutes for doxylamine succinate. The calibration curves were found to be linear from 10 to 70 μg/mL and 10 to 90 μg/mL for pyridoxine HCl and doxylamine succinate with their correlation coefficient values 0.9995 and 0.9997. LOD and LOQ were found to be 23.5 ng/mL and 71.1 ng/mL for pyridoxine HCl and 99.9 ng/mL and 302.6 ng/mL for doxylamine succinate.

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 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.

Quantification and Stability Indicating UPLC Method Development and Validation of Acalabrutinib in Bulk and Pharmaceutical Dosage Form

2021 ◽  
Vol 11 (5) ◽  
Author(s):  
V Mohan Goud ◽  
N Pooja Singh
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Theoretical Plate ◽  
Lymphocytic Leukemia ◽  
Plate Count ◽  
Pharmaceutical Dosage Form ◽  
Method Development And Validation ◽  
Development And Validation

Acalabrutinib (ABN) is a Bruton tyrosine kinase inhibitor used to treat mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma. It has been used in the treatment of Hodgkin lymphoma, multiple myeloma and ovarian cancer. It is available in capsule dosage form, usually prescribed twice a day. The objective of the present study describes the ultra-performance liquid chromatography (UPLC) method development and validation for the estimation of the ABN in Capsule dosage form by following ICH guidelines because no methods were reported in this category. The column and Mobile phase were selected based on trial and error methods. For the estimation, the chromatogram BEH C18 (50 mm x 2.1 mm, 1.7µm) column was run through with Mobile phase 0.01N KH2PO4 : Methanol in the ratio of 50:50 at a flow rate of 0.3 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected for the separation was 234nm. Retention time was achieved 1.148minute in optimized chromatogram. Theoretical plate count and tailing factor were obtained “as per recommendations of ICH limits”. The % RSD precision obtained was 0.7% and Intermediate precision obtained was 0.7% as the limit of Precision was less than 2. %Recovery obtained for marketed formulation was 99.23%. LOD, LOQ values obtained from the regression equation (y=9128.5x + 14854) of ABN were 0.18µg/ml and 0.55µg/ml respectively. Proposed method was linear over the concentration range25-150µg/ml. Different degradation studies (acid, alkali, oxidation, thermal, UV, water) were performed and all these samples passed the limits of degradation. Retention time and run time was decreased, so the method developed was simple and economical that can be adopted in regular quality control tests in Industries.

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