A NOVEL RP-HPLC METHOD FOR THE DETECTION AND QUANTIFICATION OF CLARITHROMYCIN OR SPIRAMYCIN IN BULK DRUG SAMPLES AND DOSAGE FORMS


Runako Masline Katsidzira, Anita Wessels, Marique Aucamp

Abstract


Objective: This study was aimed at developing an HPLC method that would be suitable and sufficiently robust to analyze clarithromycin or spiramycin from bulk materials, amorphous solid dispersions as well as when included into solid dosage forms.

Methods: A C8 column (250 x 4.6 mm, 5 µm) was used as stationary phase, the mobile phase consisted of 0.1 M dipotassium hydrogen orthophosphate buffer (pH 6.0) and acetonitrile in a 50:50 (% v/v) ratio. The flow rate was set to 0.5 ml/min. UV detection of 210 nm was used for clarithromycin and 232 nm for spiramycin. Ambient column and sample tray temperatures were used.

Results: The method proved to be suitable for the detection of both macrolide antibiotics in bulk samples, as part of amorphous solid dispersions as well as in dosage forms. The isocratic elution was rapid. The method was validated in terms of system suitability, limits of detection (LOD), limit of quantification (LOQ), accuracy, precision, linearity, and specificity. This method showed linearity across the concentration range of 4.0–5000.0 µg/ml for both antibiotics.

Conclusion: The developed method showed to be a simple and sufficiently sensitive method for the detection and quantification of either clarithromycin or spiramycin from samples that might contain even very small quantities of the antibiotics.


Keywords


Clarithromycin, Spiramycin, RP-HPLC

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References


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About this article

Title

A NOVEL RP-HPLC METHOD FOR THE DETECTION AND QUANTIFICATION OF CLARITHROMYCIN OR SPIRAMYCIN IN BULK DRUG SAMPLES AND DOSAGE FORMS

Keywords

Clarithromycin, Spiramycin, RP-HPLC

DOI

10.22159/ijpps.2016v8i12.15058

Date

01-12-2016

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 8, Issue 12, 2016 Page: 310-313

Online ISSN

0975-1491

Statistics

133 Views | 167 Downloads

Authors & Affiliations

Runako Masline Katsidzira
Centre of Excellence for Pharmaceutical Sciences, North-West University, Private Bag X6001, Potchefstroom, 2520, South Africa
South Africa

Anita Wessels
Department of Pharmaceutical Chemistry, School of Pharmacy, Faculty of Health Sciences, North-West University, Private Bag X6001, Potchefstroom, 2520, South Africa
South Africa

Marique Aucamp
Centre of Excellence for Pharmaceutical Sciences, North-West University, Private Bag X6001, Potchefstroom, 2520, South Africa
South Africa


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