scholarly journals Ultrafast Liquid Chromatographic Method Development and its Validation for Quantification of Telaprevir in Pharmaceutical Dosage Form by Using Quality by Design Approach

2015 ◽  
Vol 53 (7) ◽  
pp. 1193-1202 ◽  
Author(s):  
Sagar Suman Panda ◽  
Venkata Varaha Ravi Kumar Bera ◽  
Sarwar Beg ◽  
Sunil Kumar Sahu
Keyword(s):  
Dosage Form ◽  
Chromatographic Method ◽  
Method Development ◽  
Quality By Design ◽  
Design Approach ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatographic Method ◽  
Quality By Design Approach ◽  
Liquid Chromatographic

scholarly journals HPLC method development for fampridine using Analytical Quality by Design approach

2020 ◽  
Vol 70 (4) ◽  
pp. 465-482
Author(s):  
Béla Kovács ◽  
Francisc Boda ◽  
Ibolya Fülöp ◽  
István Székely-Szentmiklósi ◽  
Éva Katalin Kelemen ◽  
...  
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Design Approach ◽  
Limit Of Quantification ◽  
Elution Time ◽  
Pharmaceutical Dosage Form ◽  
Quality By Design Approach ◽  
Hplc Method Development

AbstractOffering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends. A new, experimental design-aided HPLC method for fampridine was developed and preliminarily validated according to current in-force international guidelines for linearity, accuracy, robustness and precision.The method offers a high throughput sample analysis, with an elution time of 2.9 minutes, and signal detection without excipient interference performed at 262 nm. The method proved to be linear between 1–15 µg mL−1 (R2= 0.9996). The mean recovery was found to be 98.7 ± 1.9 % in the tested range of 2.5–7.5 µg mL−1. Low RSD values (< 1 %) were obtained for both model, intra- and inter-day precision. The limit of detection and limit of quantification were 0.24 and 0.78 µg mL−1, resp. The method proved to be applicable for active substance assay in a pharmaceutical dosage form.

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