Quality by Design (QbD) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug

Vijayaraj Surendran; Palei Narahari N.; Katyayani Thummala

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Quality by Design (QbD) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug

机译：设计（QBD）散装药物估算Gliclazide估计HPLC方法的质量

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Background: Gliclazide Impurity A (GI-A) is one of the gliclazide impurities, as described in the European Pharmacopoeia.

机译：背景：Gliclazide杂质A（GI-A）是Gliclazide杂质之一，如欧洲药典所述。

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来源
《Current pharmaceutical analysis.》 |2019年第7期|共8页
作者
Vijayaraj Surendran; Palei Narahari N.; Katyayani Thummala;
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作者单位

Sree Vidyanikethan Coll Pharm Dept Pharmaceut Anal Tirupati Andhra Pradesh India;

Sree Vidyanikethan Coll Pharm Dept Pharmaceut Tirupati Andhra Pradesh India;

Sree Vidyanikethan Coll Pharm Dept Pharmaceut Anal Tirupati Andhra Pradesh India;

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原文格式 PDF
正文语种 eng
中图分类药学;
关键词
Gliclazide; Impurity A; RP-HPLC; Box Behnken design; QbD; bulk drug;

机译：Gliclazide;杂质A;RP-HPLC;Box Behnken设计;QBD;散装药物;

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1. Quality by Design (QbD) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug [J] . Vijayaraj Surendran, Palei Narahari N., Katyayani Thummala Current pharmaceutical analysis. . 2019,第7期

机译：设计（QBD）散装药物估算Gliclazide估计HPLC方法的质量
2. Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities [J] . Karmarkar S., Garber R., Genchanok Y., Journal of Chromatographic Science . 2011,第6期

机译：基于设计质量（QbD）的药物和杂质稳定性指示HPLC方法的开发
3. Quality-By-Design (QBY) Approach RP-HPLC Method for the Estimation of Nilotinib Hydrochloride and Impurities in Drug Substance [J] . Srikanth Munipalli, Tulasirao V, Vnbsp, American Journal of PharmTech Research . 2015,第6期

机译：设计质量（QBY）方法RP-HPLC方法估算盐酸尼洛替尼和药物中杂质
4. HPLC Method Research of Picoplatin-a New Platinum Anti-cancer Drug and Its Impurities [C] . LUAN Chunfang, CONG Yanwei, ZHANG Qi, 5th international conference on platinum metals : in the modern industry hydrogen energy and life maintenance in the future . 2012

机译：新型铂抗癌药物吡铂的HPLC方法研究及其杂质
5. Development and Evaluation of Desoximetasone Loaded Niosomes for Topical Drug Delivery Using Quality by Design (QbD) Approach [D] . Shah, Parinbhai B. 2021

机译：通过设计（QBD）方法，使用质量的局部药物递送的脱氧开诺酮的开发和评价
6. Developing an Improved UHPLC Method for Efficient Determination of European Pharmacopeia Process-Related Impurities in Ropinirole Hydrochloride Using Analytical Quality by Design Principles [O] . Tim Tome, Aleš Obreza, Zdenko Časar 2020

机译：开发一种改进的UHPLC方法以设计原理为依据通过分析质量高效测定欧洲药典中与盐酸罗匹尼罗有关的杂质
7. Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities [O] . S. Karmarkar, R. Garber, Y. Genchanok, 2011

机译：基于设计（QBD）的质量发展稳定性指示药物和杂质的HPLC方法

Quality by Design (QbD) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug

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