Using high-performance liquid chromatography (HPLC), a new quantitative method based on

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Using high-performance liquid chromatography (HPLC), a new quantitative method based on fingerprinting was developed to control the quality of Ribonucleic Acid for Injection II, which is used clinically as an anti-cancer drug in China. Ten batch samples were analyzed, and eight peaks were observed in the chromatograms. In total, six compounds were identified by LC-MS, including cytosine nucleotide, uracil nucleotide, guanine nucleotide, guanosine, and adenosine. The correlation coefficient of similarity and relative peak areas of characteristic compounds were calculated to quantitatively express the HPLC fingerprints. The results revealed that chromatographic fingerprints and similarity evaluations can be used to efficiently control the…show more content…
Fingerprint analysis by HPLC is widely used for the quality control of herbal drugs and displays high specificity for their identification [10-17]. To increase control over the quality of Ribonucleic Acid for Injection II, we studied and established the fingerprints of the injections in HPLC chromatograms. RNA is the active component in RNA for Injection II. however, RNA is unstable, easily biodegradable and a rather large molecule, making it difficult to detect by HPLC. Therefore, in the present experiment, RNA was hydrolyzed into nucleosides and nucleotides by an enzyme, and the hydrolyzates were detected by HPLC [18-23]. The proposed method is simple and can be used to control the quality of the injection. Moreover, the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine, which is a professional computer software program based on chemometrics, is recommended by the Chinese Pharmacopoeia Committee and is primarily applied in similarity studies on chromatographic and spectral patterns [24, 25]. In addition, the relative retention time (RRT) and relative peak area (RPA) of each characteristic peak relative to the internal standard peak have been calculated for the quantitative expression of the chemical properties of chromatographic patterns [26]. The generated data provided valuable insight into the application of the fingerprint analysis and quality

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