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| Determination of the acid amino acid in the Compound Amino Acid Injections with dynamic pH junction-sweeping combined with indirect UV detection method |
| GUO Hailong XU Xiaoying LI Yuzhen |
| Department of Pharmacy, the Eighth Affiliated Hospital, Sun Yat-sen University (Futian, Shenzhen), Guangdong Province, Shenzhen 518033, China |
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Abstract Objective To detect the content of glutamic acid (Glu) and aspartic acid (Asp) in the Compound Amino Acid Injections. Methods Dynamic pH junction-sweeping in combination with indirect UV detection method was adopted. The running buffer (pH 7.5) consists of 10 mmol/L Tris, 8 mmol/L benzoic acid and 10 mmol/L β-cyclodextrin. The sample matrix was 3 mmol/L H3PO4 solution (pH 2.5). Pressure was adopted for sample injection, and the sample injection pressure and time was 1.0 psi and 53 s, respectively. The applied voltage was 12 kV. Indirect UV detection using benzoic acid as UV probe was adopted. And the detection wavelength was set at 214 nm. Results The Glu and Asp in the Compound Amino Acid Injections were 95.9%-104.7% of their labeled amount, and the results agreed with the content limit range (95.0%-105.0%) in Chinese Pharmacopeia (2015 edition). Conclusion Dynamic pH junction-sweeping combined with indirect UV detection method can be used to determine the content of acid amino acid in Compound Amino Acid Injections. And the contents of Glu and Asp in the Compound Amino Acid Injections are in accordance with the regulations.
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