Stability-indicating methods for the determination of mosapride citrate in the presence of its degradation products according to ICH guidelines

• Published in: Drug testing and analysis Vol. 4; no. 2; pp. 104 - 115
• Main Authors: Hegazy, Maha A., Yehia, Ali M., Mostafa, Azza A.
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01-02-2012
• Subjects: Acids - metabolism; Benzamides - analysis; Benzamides - metabolism; Benzamides - standards; Drug Stability; Gastrointestinal Agents - analysis; Gastrointestinal Agents - metabolism; Gastrointestinal Agents - standards; Hydrolysis; Morpholines - analysis; Morpholines - metabolism; Morpholines - standards; mosapride; mosapride degradation products; Pharmaceutical Preparations - chemistry; Pharmaceutical Preparations - metabolism; Pharmaceutical Preparations - standards; Quality Control; Reference Standards; Sensitivity and Specificity; spectrofluorimetry; Spectrometry, Fluorescence - economics; Spectrometry, Fluorescence - methods; spectrophotometry; Spectrophotometry - economics; Spectrophotometry - methods
• ISSN: 1942-7603; 1942-7611
• DOI: 10.1002/dta.246

In the present work, different spectrophotometric methods and one spectrofluorimetric method have been developed and validated for the determination of mosapride citrate in the presence of its acid‐induced degradation products. The drug was subjected to stress stability study including acid, alkali, oxidative, photolytic, and thermal stress degradation. The developed spectrophotometric methods included the use of first order derivative (1D), derivative of ratio spectra (1DD), mean centring of ratio spectra (MC) and H‐point standard additions (HPSAM) spectrophotometric methods. For 1D method, the peaks amplitudes at 282.8 and 319.6 nm were measured, while for 1DD method those at 308 nm and 323 nm were measured. Mean centring of ratio spectra method used the values at 317 nm for calibration, while for HPSAM the absorbance at 273 and 288.6 nm were used. These methods were successfully applied for determination of mosapride in the concentration range of 5–70 µg.ml−1. The spectrofluorimetric method was based on measuring the native fluorescence of mosapride in 0.1 M NaOH using λexcitation 276 nm and λemission 344 nm and 684 nm with linearity ranges of 50–3000 ng.ml−1 and 50–9000 ng.ml−1, respectively. All the developed methods were validated according to the International Conference on Harmonization (ICH) guidelines and were applied for bulk powder and dosage form. The results obtained were statistically compared to each other using one‐way ANOVA testing. Copyright © 2011 John Wiley & Sons, Ltd.
Different spectrophotometric and a spectrofluorimetric methods have been developed and validated as stability indicating methods for the determination of mosapride citrate in presence of its acid induced degradation products, All the methods were validated according to the International Conference on Harmonization (ICH) guidelines and were applied for bulk powder and dosage form. The results obtained were statistically compared to each other using one way ANOVA testing.