Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC

2021 ◽  
pp. 5813-5818
Author(s):  
Rama Kumar Kandula ◽  
Raja Sundararajan
Keyword(s):  
Quality Control ◽  
Simultaneous Determination ◽  
Mobile Phase ◽  
Dosage Form ◽  
Regression Equations ◽  
Control Test ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Quality Control Test

Aim: To Perform Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin Tablet dosage form developed in a simple, Accurate, precise manner. Method: Agilent C18 150 x 4.6mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1.0 ml/min used for the development of chromatogram. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 260nm. Results and Conclusion: Retention time of Saxagliptin, Dapagliflozin and Metformin were found to be 2.253 min, 2.720 min, 3.276 min respectively. % RSD of the Saxagliptin, Dapagliflozin and Metformin were and found to be 0.8, 0.2 and 0.6. % Recovery was obtained as 99.60%, 100.07% and 99.95% for Saxagliptin, Dapagliflozin and Metformin respectively. LOD, LOQ values obtained from regression equations of Saxagliptin, Dapagliflozin and Metformin were 0.06, 0.12, 9.61 and 0.17, 0.36, 29.31 respectively. Regression equation of Saxagliptin is y = 40882x + 889.2, Dapagliflozin is y = 47904x + 3897 and Metformin is y = 4530.x + 35785. 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 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 A new analytical method for determination of ledipasvir and sofosbuvir in pharmaceutical formulations by HPLC method

2019 ◽  
Vol 1 (3) ◽  
pp. 59-67
Author(s):  
K. Swathi ◽  
P. Venkateswara Rao ◽  
N. Srinivasa Rao
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Precise Method ◽  
Tablet Dosage ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Sofosbuvir and Ledipasvir in Tablet dosage form. Chromatogram was run through Std Discovery C8 150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 260 nm. Retention time of Sofosbuvir and Ledipasvir were found to be 2.367 min and 3.436 min. %RSD of the Sofosbuvir and Ledipasvir were and found to be 0.6 and 0.5 respectively. %Recovery was obtained as 99.61% and 99.80% for Sofosbuvir and Ledipasvir respectively. LOD, LOQ values obtained from regression equations of Sofosbuvir and Ledipasvir were 0.67, 2.02 and 0.70, 2.12 respectively. Regression equation of Sofosbuvir is y = 4266.x + 7700, and y = 4861.x + 2656.of Ledipasvir. 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 Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

2020 ◽  
Vol 1 (4) ◽  
pp. 95-100
Author(s):  
Sonalika Patro ◽  
S. Harshith Kumar ◽  
M. Barath kumar ◽  
E. Masthaniah ◽  
K. Sairam ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Precision Study ◽  
Tablet Dosage

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

Degradation Profiling of Lisinopril and Hydrochlorothiazide by RP- HPLC method with QbD Approach

2021 ◽  
pp. 270-274
Author(s):  
Kalleshvar P. Jatte ◽  
R. D. Chakole ◽  
M. S. Charde
Keyword(s):  
Particle Size ◽  
Quality Control ◽  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Quality By Design ◽  
Hplc Method ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Gradient Mode

RP-HPLC method was developed for the estimation of Lisinopril and Hydrochlorothiazide in tablet dosage form with the help of Quality by Design (QbD) approaches. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 226.0 nm and solving the equation. The RP-HPLC method was performed C18-(100mm x 4.6 mm,)2.5 μm particle size in gradient mode, and the sample was analysed using methanol 45.0 ml and 55.0 ml (pH 3.3 0.05% OPA with TEA) as a mobile phase at a flow rate of 0.8 ml/min and detection at nm. By the retention time for Lisinopril and Hydrochlorothiazide found 3.39 and 4.59 min respectively. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 5-25 and 12.5-62.5 μg/ml for Lisinopril and Hydrochlorothiazide respectively, and recoveries from tablet dosage form were between 99.02 and 100.00 %. The method can be used for routine of the quality control in pharmaceuticals. The degradation profiling of Lisinopril and Hydrochlorothiazide were also carried out.

VALIDATED HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF OLMESARTAN MEDOXIMIL AND METOPROLOL SUCCINATE IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (10) ◽  
pp. 13-17
Author(s):  
V. V Kunjir ◽  
◽  
S. B. Jadhav ◽  
A. J Purkar ◽  
P. D. Chaudhari
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Metoprolol Succinate ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Hptlc Method

A high performance thin layer chromatographic method has been developed for the simultaneous determination of olmesartan medoximil and metoprolol succinate from tablet dosage form. The mobile phase consisting of water-methanol-ammonium sulphate (4.5:4.5:1.5 v/v/v) and wavelength of detection 233 nm was used. The developed method was validated as per ICH guidelines.

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.

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