A Validated Quantitative Estimation and Stability Indicating Reversed-phase-high Performance Liquid Chromatography Method for Balofl oxacin in Bulk and its Tablet Formulation

2014 ◽  
Vol 5 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Anusha Dacha ◽  
K. Vanitha Prakash
2020 ◽  
Vol 10 (4) ◽  
pp. 79-86
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde

A Simple, precise, and accurate stability-indicating reversed-phase high-performance liquid chromatography method has been established for the simultaneous estimation of rosuvastatin calcium and fenofibrate in combined bulk and tablet formulation. The chromatographic separation was performed on reverse phase Princeton (C18) (250 mm x 4.6 mm, 5µ) column with mobile phase as a mixture of water (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio (40:60) v/v at the flow rate 1.0 ml/min. Detection was carried out at wavelength 240 nm. The retention time under the optimized condition of Rosuvastatin calcium and Fenofibrate was found to be 2.485 & 3.905 minutes respectively. The calibration curve was linear in the range of 6-16 µg/ml and 87-232 µg/ml for rosuvastatin calcium and fenofibrate with a correlation coefficient of 0.9999 and 0.9994 respectively. Relative standard deviation values for all key parameters were less than 2.0%. The percentage recovery was found to be 99.66-100.37% and 99.13-100.44% for rosuvastatin calcium and fenofibrate respectively. The developed reversed-phase high-performance liquid chromatography method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of rosuvastatin calcium and fenofibrate in bulk and tablet formulations.  Keywords: Rosuvastatin calcium, Fenofibrate, RP-HPLC, Method validation, ICH guidelines.


2016 ◽  
Vol 7 (1) ◽  
pp. 39-47 ◽  
Author(s):  
Bhavin Pankajbhai Marolia ◽  
Pintu Bhagwanbhai Prajapati ◽  
Kunjan Bharatbhai Bodiwala ◽  
Megha Pravinkumar Vaghela ◽  
Shailesh Amritlal Shah ◽  
...  

Author(s):  
Raju Chandra ◽  
Manisha Pant ◽  
Harchan Singh ◽  
Deepak Kumar ◽  
Ashwani Sanghi

A reliable and reproducible reversed-phase high performance liquid chromatography (RP-HPLC) was developed for the quantitative determination of Remipril drug content from marketed bulk tablets. The active ingredient of Remipril separation achieved with C18 column using the methanol water mobile phase in the ratio of 40:60 (v/v). The active ingredient of the drug content quantify with UV detector at 215 nm. The retention time of Remipril is 5.63 min. A good linearity relation (R2=0.999) was obtained between drug concentration and average peak areas. The limit of detection and limit of quantification of the instrument were calculated 0.03 and 0.09 µg/mL, respectively. The accuracy of the method validation was determined 102.72% by recoveries method.


2017 ◽  
Vol 7 (2) ◽  
pp. 129-133 ◽  
Author(s):  
Juliana Kovalczuk de Oliveira ◽  
Débora Fernanda Veres Ronik ◽  
Jociani Ascari ◽  
Rubiana Mara Mainardes ◽  
Najeh Maissar Khalil

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