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To discuss the influence of the pharmaceutical excipients on the nitrosamine formation in drugs by studying the nitrate and nitrite in native starch and modified starch.
A methodologyfor the determination of nitrate and nitrite in starch was developed by ion chromatography with a suppressed conductivity detector. A Dionex IonPac anion-exchange column (AS11-HC, 4 mm, 2×250 mm) at a temperature of 30 ℃ was utilized. An electrolytically generated potassium hydroxide solution with a concentration of 0.015 mol·L-1 was delivered at a rate of 1.0 mL·min-1. The injection volume was 25 µL. The method was validated in terms of specificity, linearity, LOD & LOQ, precision, accuracy and robustness.
119 samples from 9 different categories of native starch and modified starch were analyzed. Nitrate was detected in all 38 samples of native starch in a range of 1 - 70 µg·g-1, and identified in 55 out of 81 samples of modified starch in a range of 2 - 1 110 µg·g-1, Among the modified starch samples, dextrin had the maximum concentration of nitrate. Similarly, nitrite was detected in 33 out of 38 samples of native starch in a range of 0.3 - 2.5 µg·g-1, and 17 out of 81 samples of modified starch in a range of 1.1 - 13.0 µg·g-1.
This method has been proven to be suitable for determining the nitrate and nitrite in starch based pharmaceutical excipients. The controlling of nitrate and nitrite in the pharmaceutical excipients is an important part of the nitrosamine risk control in the drugs and should be given sufficient attention.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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