Different Spectrophotometric and TLC-Densitometric Methods for Determination of Mesalazine in Presence of Its Two Toxic Impurities
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- Morcoss Martha Moheb
- Medicinal Chemistry, Faculty of Pharmacy, Nahda University
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- Abdelwahab Nada Sayed
- Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University
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- Ali Nouruddin Wagieh
- Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University
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- Elsaady Mohammed Taha
- Medicinal Chemistry, Faculty of Pharmacy, Beni-Suef University
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Abstract
<p>Two selective spectrophotometric and TLC-densitometric methods were developed for determination of mesalazine (ME) and its two toxic impurities, 4-amino phenol (4AP) and salicylic acid (SA) without preliminary separation. The proposed methods are: ratio difference in the subtracted spectra (RDSS) {Method 1}, area under the curve (AUC) {Method 2} and TLC-densitometric {Method 3}. In method {1} combination of measuring the amplitude of the constant at 350 nm (using standard spectrum of 10 µg/mL ME as a divisor) and ratio difference in the subtracted ratio spectrum for determination of 4AP and SA using the ratio difference at 221.4 and 242.2 nm, 230 and 241.2 nm, respectively. In method {2} ME was determined by direct measuring the AUC in the wavelength range of 350–370 nm while the impurities could be determined by dividing their spectra by standard spectrum of 10 µg/mL ME then interference from ME was eliminated by subtracting the amplitude of the constant at 350 nm then multiplying by the divisor. AUC in the range of 220–230 and 235–245 nm was used for measuring concentrations of 4AP and SA. On the other hand, the third method {3} is TLC–densitometric method at which chromatographic separation was achieved using ethyl acetate–methanol–triethylamine (8.5 : 2 : 0.7, v/v/v) as a developing system with UV scanning at 230 nm. The validation of the proposed methods was performed according to International Conference on Harmonization (ICH) guidelines. No significant difference was found when these methods were compared to the reported one.</p>
Journal
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- Chemical and Pharmaceutical Bulletin
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Chemical and Pharmaceutical Bulletin 64 (9), 1268-1274, 2016
The Pharmaceutical Society of Japan
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Keywords
Details 詳細情報について
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- CRID
- 1390282679153181056
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- NII Article ID
- 130005261569
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- NII Book ID
- AA00602100
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- ISSN
- 13475223
- 00092363
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- NDL BIB ID
- 027565168
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- PubMed
- 27581631
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- Text Lang
- en
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- Data Source
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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- Abstract License Flag
- Disallowed