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

Author(s):  
V. Pavan Kumar ◽  
A. Vijaya Kumar ◽  
B Sivagami ◽  
R. Charan Kumar ◽  
M. Niranjan Babu

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.

Author(s):  
Vani Gajula ◽  
Thejomoorthy K ◽  
Sreenivasa Prasanna P

A simple, Accurate, precise method was developed for the simultaneous estimation of the Indacaterol and Glycopyrronium in the bulk and pharmaceutical dosage form. The chromatogram was run through Std Denali C18150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1%OPA: Acetonitrile taken in the ratio 55:45 was pumped through the column at a flow rate of 0.8 ml/min. The buffer used in this method was 0.1% OPA buffer. The temperature was maintained at 30°C. The optimized wavelength selected was 230.0 nm. The retention time of Indacaterol and Glycopyrronium were found to 2.323min and 3.140 %RSD of the Indacaterol and Glycopyrronium were %RSD found to be 0.2% and 0.2% respectively. %Recovery was obtained as 99.39% and 99.41% for Indacaterol and Glycopyrronium respectively. LOD, LOQ values obtained from regression equations of Indacaterol and Glycopyrronium were 1.08, 3.28, and 0.25, 1.47 respectively. Regression equation of Indacaterol is y = 24501x + 7142.3, y = 26335x + 7822.7of Glycopyrronium.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.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 49-56
Author(s):  
H Joshi ◽  
A. Khristi ◽  

A simple, accurate, precise, reproducible and economic method developed and validated for the simultaneous estimation of teneligliptine hydrobromide hydrate (TENE) and metformin hydrochloride (MET HCl) in pharmaceutical dosage form. TENE and MET HCl were estimated on Thermoscientific C18 column using mobile phase 0.01M PDP: methanol (45:55 % v/v) (pH 3.5 adjusted with 5% acetic acid) at flow rate 1.0 mL/min. Detection was carried out at 254 nm. The retention time of teneligliptine hydrobromide hydrate and metformin hydrochloride were 7.77 min and 2.64 min, respectively. The linearity was found to be 4-12 μg/mL and 100-300 μg/mL for TENE and MET HCl respectively. R2 value was found to be 0.998 and 0.995. For the assay method % recovery was found in the range of 98.16 – 101 for TENE and MET HCl. The LOD and LOQ were found to be 0.3527 and 1.0690 for TENE and 0.5077 and 1.538 for MET HCl respectively. Method was validated as per ICH guidelines.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.


2014 ◽  
Vol 1 (3) ◽  
pp. 50
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Jambulingam Munusamy ◽  
Saravanakumar Sengodan ◽  
Kamalakannan Danapal ◽  
Haritha D Siva Ganga Lakshmi ◽  
...  

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