Why is Analytical Method Validation Required? : Pharmaguideline

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Why is Analytical Method Validation Required?

Analytical method validation is a process used to ensure that an analytical method is fit for its intended purpose.
Analytical method validation is documented evidence that any analytical method used for the analysis of any product is suitable, reliable and produces consistent results. We can say that a validated analytical method produces reliable and authentic results.

An analytical method is required to validate before its routine use for analysis of pharmaceutical products. Revalidation is also required when:
  • There is any change in the technique
  • There is any change in the existing procedure
  • There is any change in dilution or concentration

Requirements of Analytical Method Validation

  • Details of components to be detected and quantified
  • Expected concentration levels of sample
  • Required accuracy and precision
  • Analytical technique used for analysis
  • Materials and equipment required for analysis
  • Total cost of analysis

Parts of  an Analytical Method Validation


Specificity is the ability of the analytical method to detect the analyte in the presence of the interfering components of the sample. This test is done in analytical method validation to demonstrate that the method is able to detect the specific compound without the impact of interfering factors present in the sample.


The analytical method should have linear results. This means that the sample concentration and the detector response graph should be linear. Generally, 5 different concentrations of analyte are analyzed in the system and a graph is plotted between concentration and signal response. The graph must be linear.
Related: Analytical Method Validation


The upper and lower limit of the method that it can measure the analyte in the sample. The analytical method should be able to detect the very low amount of the analyte present in the sample.


Accuracy is the closeness of the analytical results to the theoretical values of the analyte in the sample. It shows how much the method is accurate in the detection of an analyte in the sample. It is determined by the percent recovery of the theoretical values.

Limit of detection

The lowest amount of the analyte that can be detected by the analytical method is known as the limit of detection. It shows that how much the method is capable to detect the analyte.

Limit of quantification

The lowest limit of the analyte that can be quantified by the analytical method is known as limit of quantification. It is the limit of method that can quantify an analyte means how much analyte in sample it can measure.


A robustness test is done to determine the stability of the analytical method. It shows the reliability of the analytical results with respect to the variations in method parameters.

Factors affecting the analytical results in pharmaceutical analysis

Following factors may affect the analytical results
  • Type of column used
  • pH value of sample
  • Composition of mobile phase
  • Sample flow rate
  • Column oven temperature
  • Composition of buffer

Why is Analytical Method Validation Required?

Validation is required to obtain accurate and precise results of the pharmaceutical products. There are many benefits of an analytical method validation but some of them are listed below.

1. Regulatory requirement

Analytical method validation is an essential part of good manufacturing practices. FDA, ICH and other regulatory probabilities require validation of analytical methods unit for analysis of the products. These compliances are necessary for every pharmaceutical manufacturing company.

2. An increased efficiency

Due to analytical method validation the efficiency of work increases Because method and method parameters are predefined and fixed, analysts do not take much time to prepare the sample and the system for analysis. Due to this the time and efforts are saved that are used in the analysis of the product. It saves you money for the company in the long term.

3. Data Accuracy

Due to the presence of a validated analytical method, accuracy of the analysis is increased. Analytical data is considered more accurate and reliable when analytical methods are used for the analysis of the product.

4. Better Customer Satisfaction

Customer satisfaction is increased when the accuracy of an analytical method is increased. Customers need more secure and effective products. The effectiveness of a product is measured by the accuracy of the analytical results of the product. Analytical methods validation helps to reduce market complaints and other related problems.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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