高效液相色谱法测定纯药物和制剂中苦参及其工艺相关杂质的建立与应用

Q4 Pharmacology, Toxicology and Pharmaceutics Toxicology International Pub Date : 2023-09-20 DOI:10.18311/ti/2023/v30i3/33573
Jammu Harish, Bodasingi Sai Kumar, Uppu Naga Babu, Gattupalli Subhakara Rao, Venkateswara Rao Anna
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引用次数: 0

摘要

杂质分析在确保消费者安全的安全药品生产中起着重要作用。考虑到这一点,本研究拟建立一种简便、灵敏的高效液相色谱方法来分离和定量阿霉素纯药及制剂中杂质1、2、3和4。该方法使用绿色溶剂作为流动相,在ProntoSIL ODS-C18 (250×4.6 mm;5 μ id)色谱柱,室温下为固定相,乙醇和0.1%水乙酸以65:35 (V/V), pH 4.5为流动相,流速为0.8 mL/min,紫外检测波长为246 nm。该方法在保留时间分别为7.05、4.52、6.09、2.88和8.14 min时检测到alpelisib、杂质1、2、3和4。分析在15分钟的运行时间内完成,消耗较少的溶剂和相同的分析时间。该方法在12.5 ~ 100 μg/mL和0.0125 ~ 0.10 μg/mL的范围内线性良好。该方法可以有效地解决研究中alpelisib在应力暴露过程中产生的未知应力降解产物及其已知杂质。其他验证研究的结果同样令人满意,并被证明足以常规分析原料药和片剂剂量中的alpelisib及其工艺相关杂质。
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Development and Application of a Validated HPLC Method for the Determination of Alpelisib and its Process-Related Impurities in Pure Drug and Pharmaceutical Formulations
Impurity analysis plays a significant role in the manufacture of a safe pharmaceutical product that ensures the safety of consumers. Keeping this in consideration, the present study was intended to develop a simple and sensitive HPLC method for the resolution and quantification of 4 process-related impurities namely impurities 1, 2, 3 and 4 in alpelisib pure drug and formulations. The method consumes greener solvents as a mobile phase that resolves the analytes on ProntoSIL ODS-C18 (250×4.6 mm; 5 μ id) column at room temperature as stationary phase, ethanol and 0.1% aqueous acetic acid in 65:35 (V/V) at pH 4.5 as mobile phase at 0.8 mL/min flow rate, UV detection at 246 nm. The method can detect the analytes at retention times of 7.05, 4.52, 6.09, 2.88 and 8.14 min respectively for alpelisib, impurity 1, 2, 3 and 4. The analysis was completed with a run time of 15 min that consume less solvent and the same analysis time. The linearity of the proposed method was perceived in the range of 12.5 to 100 μg/mL for alpelisib and 0.0125 to 0.10 μg/mL for impurities. The method can effectively resolve the unknown stress degradation products generated during the stress exposure of alpelisib along with its known impurities in the study. The outcomes of other validation studies were likewise satisfactory and proven adequate for regular analysis of alpelisib and its process-related impurities in bulk drug and pharmaceutical tablet doses.
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来源期刊
Toxicology International
Toxicology International Environmental Science-Health, Toxicology and Mutagenesis
CiteScore
0.60
自引率
0.00%
发文量
23
期刊介绍: Toxicology International is a peer-reviewed International Research Journal published bi-annually by the Society of Toxicology, India. The Journal is concerned with various disciplines of Toxicology including man, animals, plants and environment and publishes research, review and general articles besides opinions, comments, news-highlights and letters to editor.
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