Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Review Article Volume 4 Issue 4

New Method Development by HPLC and Validation as per ICH Guidelines

Arunadevi Shantappa Birajdar*

Professor, K.T. Patil College of Pharmacy, Osmanabad, Maharashtra, India

*Corresponding Author: Arunadevi Shantappa Birajdar, Professor, K.T. Patil College of Pharmacy, Osmanabad, Maharashtra, India.

Received: March 05, 2020; Published: March 23, 2020

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Abstract

  This Scientific paper consists of the information of HPLC new method development and Validation as per ICH Guidelines. It also explains importance of HPLC method development and types of HPLC columns. In this paper new binger clearly understand how new method development carried out and what are the ICH guidelines regarding any new method development by HPLC. In First step we have to check solubility of the APIs in same solvent and find out the absorption range and lambda Max. Then by dilution the API in range of Absorbance find out Linearity curve for both compounds single as well as in mixture. This method then applied on formulations as its application. The ICH guidelines explained in detail as validation parameters such as Selectivity, Linearity, Accuracy and precision, LOD and LOQ, Ruggedness and Robustness, Stability and system suitability and it’s std values. It will help to budding students for new method development and it’s validation.

Keywords:HPLC Method Development; Validation; ICH Guidelines; System Suitability

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Citation

Citation: Arunadevi Shantappa Birajdar. “New Method Development by HPLC and Validation as per ICH Guidelines". Acta Scientific Pharmaceutical Sciences 4.4 (2020): 55-60.



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