DEVELOPMENT AND VALIDATION BY HPLC METHOD
Authors/Creators
- 1. Research Scholar, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur
- 2. Professor, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur
- 3. Principal, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur
Description
Validation of an analytical procedure is the process of demonstrate with suitable for its
intended purpose. Chromatographic such HPLC methods play significant role in the
pharmaceutical industry from the drug discovery, development of drugs, formulations and
quality control of chemicals. Many validated analytical methods ensure that it provides
consistent, reliable and accurate data for results. So these methods help pharmaceutical
analyst to ensure quality products are released for market. This review explains general
approach for validation process and validation parameters to be considered during validation
of a HPLC method. It also used to refer for various regulatory requirements. The parameters
described follow to ICH guidelines and include accuracy, precision, specificity and limit of
detection, limit of quantitation, linearity, range and robustness.
Abstract (English)
Validation of an analytical procedure is the process of demonstrate with suitable for its
intended purpose. Chromatographic such HPLC methods play significant role in the
pharmaceutical industry from the drug discovery, development of drugs, formulations and
quality control of chemicals. Many validated analytical methods ensure that it provides
consistent, reliable and accurate data for results. So these methods help pharmaceutical
analyst to ensure quality products are released for market. This review explains general
approach for validation process and validation parameters to be considered during validation
of a HPLC method. It also used to refer for various regulatory requirements. The parameters
described follow to ICH guidelines and include accuracy, precision, specificity and limit of
detection, limit of quantitation, linearity, range and robustness.
Files
IJCPR,Vol14,Issue3,Article13.pdf
Additional details
Dates
- Accepted
-
2022-09-28