The objective of the current investigation was to develop a simple, rapid, and stability-indicating high-performance liquid chromatography method and to study the degradation behavior of sulfapyridine (SP) under different International Conference on Harmonization (ICH)-recommended conditions. The chromatographic method was developed using C18 (250 × 4.6 mm, 5 μ) column, and mobile phase consisting of acetonitrile-0.1% formic acid (30:70 v/v) at ambient temperature, at a flow rate of 1 mL/min. The elution was monitored at 265 nm using a photodiode array detector. The developed method was subsequently validated as per ICH Q2 (R1) guidelines. The retention time of SP was observed as 4.56 min with the linearity range between 2 to 10 μg/mL. Limit of detection and limit of quantitation for SP were 0.115 and 0.35 μg/mL, respectively. Forced degradation studies were carried out on bulk samples of SP using prescribed acidic, basic, oxidative, thermal, and photolytic conditions. Extent of degradation in 0.1 M hydrochloric acid and under photolytic conditions was found to be 21.56% and 28.57%, respectively. The degradation products formed in stress conditions were identified by liquid chromatography-mass spectrometry (LC-MS). The utility of the method was verified by quantification of SP in different laboratory-made pharmaceutical preparations. The proposed method could be successfully used to quantify SP in different pharmaceutical dosage forms.

中文翻译：

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高效液相色谱法和液相色谱/质谱法研究磺胺吡啶的应力降解行为，并开发出经过验证的，特异性，稳定性指示的HPLC分析方法。

当前研究的目的是开发一种简单，快速，指示稳定性的高效液相色谱方法，并研究在国际协调会议（ICH）推荐的不同条件下磺胺吡啶（SP）的降解行为。色谱方法是使用C18（250×4.6 mm，5μ）色谱柱开发的，流动相由环境温度下的乙腈-0.1％甲酸（30:70 v / v）组成，流速为1 mL / min 。使用光电二极管阵列检测器在265 nm处监测洗脱。随后根据ICH Q2（R1）指南对开发的方法进行了验证。SP的保留时间为4.56分钟，线性范围为2至10μg/ mL。SP的检出限和定量限分别为0.115和0.35μg/ mL。在规定的酸性，碱性，氧化，热和光解条件下，对SP的大量样品进行了强制降解研究。发现在0.1M盐酸中和在光解条件下的降解程度分别为21.56％和28.57％。通过液相色谱-质谱法（LC-MS）鉴定在应力条件下形成的降解产物。通过定量不同实验室制备的药物制剂中的SP验证了该方法的实用性。所提出的方法可以成功地用于定量不同药物剂型中的SP。分别。通过液相色谱-质谱（LC-MS）鉴定了在应力条件下形成的降解产物。通过定量不同实验室制备的药物制剂中的SP验证了该方法的实用性。所提出的方法可以成功地用于定量不同药物剂型中的SP。分别。通过液相色谱-质谱法（LC-MS）鉴定在应力条件下形成的降解产物。通过定量不同实验室制备的药物制剂中的SP验证了该方法的实用性。所提出的方法可以成功地用于定量不同药物剂型中的SP。