A rapid, developed and validated RP-HPLC method for determination of azithromycin

Abstract

Azithromycin (Azr) is a member of the macrolide antibiotic and it used on a wide scale in prescribed antibiotic drugs as anti-gram-positive and anti-gram-negative microorganisms. The present study aimed to develop an HPLC method of Azr analysis enjoyed highly linearity, repeatability, robust, rugged, selective and rapid to use. The chromatographic method uses a reversed phase column ODS-3 (250 mm × 4.6 mm x 5 μm). The mobile phase was prepared by mixing Methanol: Phosphate buffer (9:1, v/v) at flow rate 1.2 ml/min with PDA detector 210 nm, column oven adjusted to 40° C with injection volume 50 μL. The method revealed satisfied linearity regression R 2 (0.9996) with repeatability (0.66%), LOD and LOQ 28.7 µg/ml and 86.9 µg/ml respectively. The method showed a successful application for Azr determination in bulk and pharmaceutical formulations.

A review of green methods for phyto-fabrication of hematite (α-Fe2O3) nanoparticles and their characterization, properties, and applications

“…Recently, the scientific research has been primarily directed to ensure the precision and accuracy of the results and their validity in terms of repeatability, robustness, and rigidity for the need to keep track and to carry out periodic maintenance requirements for the analysis instruments through calibration and the validation implementation for using of the analysis methods, according to specific rules, conditions and regulations and standard operating procedures [ 114 , 115 , 116 , 117 , 118 ].…”

Biogenic copper nanoparticles and their applications: A review

“…The method of analysis used for the determination of the analyte amount may be either old fashion analysis methods or modern instrumental analysis methods. Titrations, Uv-Vis spectrophotometry, Spectrofluorimetric, Voltammetric, inductively coupled plasma, Chromatography as HPLC, GC; or any analysis method, it should be validated according to validation guidelines [167][168][169].…”

Fully investigation of rp- hplc analytical method validation parameters for determination of cefixime traces in the different pharmaceutical dosage forms and urine analysis

“…The validation of the HPLC method was carried out according to International Conference on Harmonization (ICH), Food and Drug Administration (FDA), United States of American Pharmacopoeia (USP) and European Pharmacopoeia (EP) guidelines concerning parameters including tuning system and suitability of the system, Range linearity, detection limit, quantification limit, repeatability, recovery and accuracy, robustness, ruggedness, the stability of the solution, specificity and selectivity [20][21][22][23][24][25] .…”

“…It was said the method is linear if there is a good proportion between the response and working concentration starting from the lowest point in the tested range and the highest point and the R 2 should be ≥ 0.999 [20][21][22][23][24] .…”

“…It was defined as the minimum concentration of the analyte in the matrix that can be distinguished using the instrument detector. Additionally, it should not be represented in the precision and linearity range [20][21][22][23][24] .…”