A Review On: Development and Validation of HPLC in Pharmaceutical Dosage Form

  • Bharat Dadhich Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India
  • Rakesh Goyal Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India
  • Dilip Agarwal Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

Abstract

HPLC is the dominant separation technique in modern pharmaceutical and biomedical analysis because it results in highly efficient separations and in most cases provides high detection sensitivity. Most of the drugs in multi component dosage forms can be analyzed by HPLC method because of the several advantages like rapidity, specificity, accuracy, precision and ease of automation in this method. HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic. This review gives information regarding various stages involved in development and validation of HPLC method. Validation of HPLC method as per ICH Guidelines covers all the performance characteristics of validation, like Accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness and system suitability testing.


 


 

Keywords: HPLC, Method development, Validation.

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Author Biographies

Bharat Dadhich, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

Rakesh Goyal, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

Dilip Agarwal, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India

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How to Cite
Dadhich, B., Goyal, R., & Agarwal, D. (2020). A Review On: Development and Validation of HPLC in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Research and Development, 8(4), 110-121. https://doi.org/https://doi.org/10.22270/ajprd.v8i4.656