A rapid RP‐HPLC stability‐indicating method development and validation of moxifloxacin hydrochloride–related substances in finished dosage forms

Abstract

A reversed‐phase high‐performance liquid chromatography (RP‐HPLC) method was developed and validated for the identification and quantification of moxifloxacin hydrochloride–related substances in finished dosage forms. Chromatographic separation was achieved on an Agilent C18 column (150 × 4.6 mm, 5 μm) with the mobile phase (0.01 M potassium dihydrogen orthophosphate as buffer and methanol in the ratio of 70:30) eluted in isocratic mode. The HPLC flow rate was 1.0 mL min−1, and peaks were monitored at 230 nm using a photodiode array (PDA) detector. The column temperature was kept constant at 30°C, and the injection volume was 10 μL. The run time of the method was 16 min. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Linearity was recorded at various concentrations ranging from 0.25 to 1.5 μg mL−1 for all the moxifloxacin impurities. Linearity, regression value, recovery, %relative standard deviation (RSD) of method precision values were found within the acceptance limits. The method for related substances (RS) in moxifloxacin was found to be specific, linear, accurate, precise, rugged, and robust. The validated method was suitable for the quantification of the RSs in moxifloxacin drug products. The method was applied in quality control lab for the analysis of moxifloxacin impurities in stability analysis.

Long-term physicochemical stability of 5-fluorouracil at selected standardised rounded doses in polyolefin bags

“…20 The results of the validation show a between-day reproducibility of 6% which is possibly linked to the 100-fold dilution of the solutions before injection in the system. This coefficient of variation remains under the limit of 10% 25 but could influence the 95% confidence interval on the mean which is affected by the variability of the concentration of the bags and by the variability of the measurements.…”

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

“…The proposed method has similar greenness comparing to the pharmacopoeial methods and four other reported methods. 1,2,4,6,10,11 The red zones in GAPI pentograms for sampling denote mandatory offline sampling. The advantage of the proposed method is that only 7.5% (v/v) isopropanol is used in the mobile phase compared with published methods.…”

“…Also, most reported HPLC methods for determination of moxifloxacin and its impurities use a high percentage of organic solvents (methanol or acetonitrile) in the mobile phase which cannot be considered as environmentally friendly solvents. [4][5][6][7][8][9][10][11] Micellar liquid chromatography (MLC) method has been investigated as an interesting approach for green analytical chemistry (GAC), as it eliminates or reduces the use of organic solvents and uses mobile phases containing 90% (v/v) or more water. [12][13][14][15][16][17] MLC is attractive due to its lower cost, lower toxicity, greater stability, reduced negative impact on the environment and greater safety for laboratory use.…”