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首页> 外文期刊>Pharmaceutical Methods >New Stability Indicating LC Method for Novel Antidiabetic Drug Canagliflozin Hemihydrate Quantification; Development and Validation
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New Stability Indicating LC Method for Novel Antidiabetic Drug Canagliflozin Hemihydrate Quantification; Development and Validation

机译：新型抗糖尿病药物Canagliflozin半水合物定量的新的稳定性指示LC方法;开发与验证

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Introduction: The present research includes a new RP-HPLC method development and validation of Canagliflozin Hemihydrate (CANAG) a novel antidiabetic drug. The novel analytical method developed was employed for the quantification of CANAG in bulk drug and as an Active Pharmaceutical Ingredient (API) in tablet formulation. Methods: The present study utilized HPLC instrument (Shimadzu) comprises of ultraviolet detector and COSMICSIL 100 Csub18 /sub(250 × 4.6 mm) 5 μm column. The mobile phase consists of acetonitrile: water (70:30%v/v) of pH 3.0±0.05 adjusted by addition of ortho-phosphoric acid. The chromatographic conditions were, flow rate 1 ml/min, run time 6.0 min, injection volume 20 μl and detection wavelength 282 nm at room temperature. The developed method was validated as per International Conference on Harmonization (ICH) guidelines for achieving robustness and accuracy. Forced degradation studies were carried out to prove the capability of the developed method to quantify the CANAG analyte response in presence of degraded products. Results: The presently developed novel analytical method possesses a shorter retention time 4.1 min. The results of validation parameters suggested that the presently developed method was robust and accurate since %RSD, theoretical plates and tailing factor values were within the limits of ICH guidelines. The predominant principle peak was observed in the chromatogram for CANAG without any interference from peaks of the degraded products. Conclusion: The present research study concluded that the developed analytical method for CANAG was novel, robust accurate and the principle peak of CANAG was not affected by presence of degraded and products. The same method can be employed for analysis of CANAG as a bulk drug and as API in formulation.
机译：简介：本研究包括一种新的RP-HPLC方法开发和Canagliflozin Hemihydrate（CANAG）一种抗糖尿病药物的验证。开发的新型分析方法用于定量散装药物中的CANAG，并用作片剂中的活性药物成分（API）。方法：本研究使用的HPLC仪器（Shimadzu）由紫外检测器和COSMICSIL 100 C 18 （250×4.6 mm）5μm色谱柱组成。流动相由pH为3.0±0.05的乙腈：水（70：30％v / v）组成，可通过添加正磷酸进行调节。色谱条件为室温下流速为1 ml / min，运行时间为6.0 min，进样量为20μl，检测波长为282 nm。所开发的方法已根据国际协调会议（ICH）指南进行了验证，以实现鲁棒性和准确性。进行了强制降解研究，以证明所开发方法量化存在降解产物时CANAG分析物响应的能力。结果：目前开发的新型分析方法具有较短的保留时间4.1分钟。验证参数的结果表明，由于％RSD，理论塔板数和拖尾因子值均在ICH指南的范围内，因此当前开发的方法是可靠且准确的。在CANAG色谱图中观察到主要的主峰，而不受降解产物峰的干扰。结论：本研究得出的结论是，所开发的CANAG分析方法新颖，可靠，准确，并且降解和产物的存在不会影响CANAG的主峰。相同的方法可用于分析CANAG作为原料药和制剂中的API。

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