Clorprenaline hydrochloride (CLOR), β₂ adrenergic agonist, was used for the therapeutic treatment for bronchial asthma. It is important to know the stability behavior of the drug in various degradation conditions because the drug is incompatible with strong oxidizing agent and strong base. The main objective of the study was to identify and characterize degradation products of clorprenaline HCl by LC–MS/MS. The mass-compatible method was developed, validated and further used for LC–MS/MS. In reverse-phase high-performance liquid chromatography (RP-HPLC), the resolution was achieved using Phenomenex C₁₈ (250 × 4.6 mm, 5 µ) column and ammonium acetate buffer (5 mM), 0.1% TEA, pH 6.5 with acetic acid/methanol (70:30, v/v) as mobile phase. The flow rate was 1 mL/min. The wavelength was selected for UV detection at 215 nm. Different forced degradation conditions such as hydrolytic (acidic and basic), oxidative, thermal and sunlight have been applied according to ICH Q1A (R2) guidelines to derive stability of the drug. Further, the method was validated as per ICH Q2 (R1) guidelines. The degradation product was characterized by LC–MS/MS using ESI in positive ion mode. Potential degradation product DP (36.87% of total degradation) was found in basic condition, while no degradation was observed in acidic, neutral, sunlight, oxidation and thermal conditions. The stability indicating analytical method was found to be novel, simple, specific, selective, sensitive, accurate, precise and robust for the determination of clorprenaline HCl.

中文翻译：

---

关于盐酸氯雷普萘林降解产物的第一份报告：通过LC-MS / MS进行鉴定和表征

盐酸氯丙那林（CLOR），β ₂肾上腺素能激动剂，用于治疗性治疗支气管哮喘。重要的是要知道药物在各种降解条件下的稳定性，因为药物与强氧化剂和强碱不相容。该研究的主要目的是通过LC-MS / MS鉴定和表征盐酸氯雷普林的降解产物。质量兼容的方法已经开发，验证并进一步用于LC-MS / MS。在反相高效液相色谱（RP-HPLC）中，使用Phenomenex C ₁₈达到了分离度 （250×4.6 mm，5 µ）柱和乙酸铵缓冲液（5 mM），0.1％TEA，pH 6.5，乙酸/甲醇（70:30，v / v）作为流动相。流速为1mL / min。选择波长以在215 nm处进行UV检测。根据ICH Q1A（R2）指南，已采用了不同的强制降解条件，例如水解（酸性和碱性），氧化，热和日光，以求得药物的稳定性。此外，该方法已按照ICH Q2（R1）指南进行了验证。使用正离子模式的ESI通过LC-MS / MS对降解产物进行表征。在碱性条件下发现潜在的降解产物DP（占总降解的36.87％），而在酸性，中性，日光，氧化和热条件下均未观察到降解。发现稳定性指示分析方法新颖，简单，专一，选择性，