scholarly journals The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities

RSC Advances ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 7313-7320
Author(s):  
Joanna Wittckind Manoel ◽  
Gabriele Bordignon Primieri ◽  
Lívia Maronesi Bueno ◽  
Nathalie Ribeiro Wingert ◽  
Nádia Maria Volpato ◽  
...  
Keyword(s):  
Quality Control ◽  
Liquid Chromatography ◽  
Quality By Design ◽  
Chromatography Method ◽  
Pharmaceutical Ingredients ◽  
Organic Impurities ◽  
Liquid Chromatography Method

Analysis of impurities is an important step in the quality control of pharmaceutical ingredients and final products.

Fast high-performance liquid chromatography method for quality control of soy extracts

2004 ◽  
Vol 1038 (1-2) ◽  
pp. 107-112 ◽  
Author(s):  
Sandra Apers ◽  
Tania Naessens ◽  
Katleen Van Den Steen ◽  
Filip Cuyckens ◽  
Magda Claeys ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Chromatography Method ◽  
Liquid Chromatography Method

scholarly journals Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

2014 ◽  
Vol 50 (1) ◽  
pp. 213-223 ◽  
Author(s):  
Tahisa Marcela Pedroso ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Pharmaceutical Industry ◽  
High Performance ◽  
Fractional Factorial ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Cefazolin Sodium ◽  
Liquid Chromatography Method

A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2=0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy.

Sign in / Sign up

Export Citation Format

Share Document