Improved high-performance liquid chromatographic assay of erythromycin in pharmaceutical solid dosage forms

1987 ◽  
Vol 396 ◽  
pp. 191-198 ◽  
Author(s):  
Tara Geria ◽  
Wen-Hai Hong ◽  
Robert E. Daly
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Liquid Chromatographic

scholarly journals Stability Indicating HPLC-ECD Method for the Analysis of Clarithromycin in Pharmaceutical Dosage Forms: Method Scaling versus Re-Validation

2019 ◽  
Vol 87 (4) ◽  
pp. 31 ◽  
Author(s):  
Makoni ◽  
Chikukwa ◽  
Khamanga ◽  
Walker
Keyword(s):  
High Performance ◽  
The United States ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Analytical Column ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Run Time ◽  
Liquid Chromatographic

An isocratic high-performance liquid chromatographic method using electrochemical detection (HPLC-ECD) for the quantitation of clarithromycin (CLA) was developed using Response Surface Methodology (RSM) based on a Central Composite Design (CCD). The method was validated using International Conference on Harmonization (ICH) guidelines with an analytical run time of 20 min. Method re-validation following a change in analytical column was successful in reducing the analytical run time to 13 min, decreasing solvent consumption thus facilitating environmental and financial sustainability. The applicability of using the United States Pharmacopeia (USP) method scaling approach in place of method re-validation using a column with a different L–designation to the original analytical column, was investigated. The scaled method met all USP system suitability requirements for resolution, tailing factor and % relative standard deviation (RSD). The re-validated and scaled method was successfully used to resolve CLA from manufacturing excipients in commercially available dosage forms. Although USP method scaling is only permitted for columns within the same L-designation, these data suggest that it may also be applicable to columns of different designation.

scholarly journals Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC

2009 ◽  
Vol 6 (2) ◽  
pp. 541-544 ◽  
Author(s):  
D. Anantha Kumar ◽  
D. P. Sujan ◽  
V. Vijayasree ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Ammonium Acetate ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Reverse Phase ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of simvastatin and ezetimibe in tablet dosage forms. The separation was effected on a C18 Supelcosil column (250 mm x 4.6 mm; 5µ) using a mobile phase consisting of 0.01 M ammonium acetate buffer and acetonitrile (35:65v/v) at a flow rate of 1 mL/min. The detection was made at 240 nm. The retention times for ezetimibe and simvastatin were 5.9 and 8.5 min respectively. Calibration curves were linear over the ranges of 0.5-40 µg/mL for simvastatin and 2.5-50 µg/mL for ezetimibe. The proposed method was validated as per the ICH and USP guidelines. The method is accurate and precise and found to be suitable for the quantitative analysis of both the drugs individually and in combination in tablet dosage forms.

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