The Advantage of the Chemometric Method in Determining Levels

Oct 13, 2025 by wbrum.org 69 views

Background

The use of anti-hypertensive drugs, such as amlodipin, valsartan, and hydrochlorotiazid, has become increasingly common in the treatment of high blood pressure. These medications are often used in combination to provide effective and safe blood pressure control. However, the quality of these medications can be compromised if the levels of each component are not accurately determined. Therefore, it is essential to develop a reliable method for determining the levels of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations.

Objective

This study aims to validate the ultraviolet spectrophotometry method with calibration of multivariate partial least square (PLS) in determining the level of mixture of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations. The objective of this study is to develop a reliable and accurate method for determining the levels of these medications in tablet preparations.

Method

The calibration and validation models of chemometrics were performed by measuring absorbance at certain wavelengths (230-300 Nm for amlodipin, 220-290 Nm for valsartan, and 230-300 nm for hydrochlorotiazid) for five different concentrations. The R2, Press, and RMSECV values were evaluated to assess the model prediction capabilities.

Results

The results of this study showed that the method used is declared valid with good precision results, indicated by the relative standard deviation (SBR) for amlodipin, valsartan, and hydrochlorotiazids of 1.1747%, 0.4071%, and 0.4991%, respectively. The accuracy of the method is also high, evidenced by the percentage of re-acquisition which reached 99.06% for Amlodipin, 99.56% for Valsartan, and 99.73% for hydrochlorotiazid.

Multivariate PLS calibration shows good prediction capability with RMSECV value of 0.0214 for Amlodipin, 0.30179 for valsartan, and 0.0018 for hydrochlorotiazid. The press value obtained also shows good prediction capability with a value of 0.0260 for amlodipin, 0.5085 for valsartan, and 0.1764 for hydrochlorotiazid. The R2 value close to 1 (0.99972 for amlodipin, 0.99948 for valsartan, and 0.99997 for hydrochlorotiazid) indicates a high model compatibility.

The results of determining the levels of amlodipin, valsartan, and hydrochlorotiazid in tablets showed the results in accordance with the specified level requirements, namely 99.59% for amlodipin, 101.92% for valsartan, and 103.60% for hydrochlorothiazid.

Conclusion

Based on the results of the study, it can be concluded that the ultraviolet spectrophotometry method with Multivariate PLS calibration can be used effectively to determine the levels of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations. This method is proven to be valid and meets the levels of levels stipulated in USP 43 NF38 (2020) and Pharmacopoeia edition VI (2020).

The Advantage of the Chemometric Method in Determining Levels

The chemometric method has several advantages in determining levels, namely:

Increasing Efficiency

The chemometric method allows simultaneous analysis of various components in a sample, so that the analysis process is faster and more efficient compared to conventional analysis methods.

Increasing Sensitivity

The chemometric method can increase the sensitivity of the analysis by utilizing more complete spectral information.

Increasing Accuracy

The chemometric method can increase the accuracy of analysis by correcting systematic errors and reducing noise in data.

The Importance of Testing Levels in Tablet Preparations

Level testing is one of the important aspects in the quality control of pharmaceutical preparations. This test ensures that the tablet contains the right amount of active ingredients according to those listed on the label and meet the established quality standards. This is very important to ensure the safety and effectiveness of drugs for patients.

Further Research

Further research can be done to study more details about the effect of other factors on the accuracy and precision of this method, such as variations in making tablets or storage conditions. In addition, this method can be applied to analyze the combination of other anti-hypertensive drugs available in the form of tablets.

Limitations of the Study

This study has several limitations, including:

The study only focused on the determination of amlodipin, valsartan, and hydrochlorotiazid levels in tablet preparations.
The study did not investigate the effect of other factors on the accuracy and precision of the method.
The study did not compare the results of the chemometric method with other analytical methods.

Future Directions

Future studies can be conducted to:

Investigate the effect of other factors on the accuracy and precision of the chemometric method.
Compare the results of the chemometric method with other analytical methods.
Apply the chemometric method to analyze the combination of other anti-hypertensive drugs available in the form of tablets.

Conclusion

In conclusion, the ultraviolet spectrophotometry method with Multivariate PLS calibration can be used effectively to determine the levels of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations. This method is proven to be valid and meets the levels of levels stipulated in USP 43 NF38 (2020) and Pharmacopoeia edition VI (2020). Further research is needed to study more details about the effect of other factors on the accuracy and precision of this method.

Q: What is the purpose of determining the levels of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations?

A: The purpose of determining the levels of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations is to ensure that the tablet contains the right amount of active ingredients according to those listed on the label and meet the established quality standards. This is very important to ensure the safety and effectiveness of drugs for patients.

Q: What is the chemometric method, and how does it work?

A: The chemometric method is a statistical approach that uses mathematical models to analyze data from various analytical techniques, such as spectrophotometry. In this study, the chemometric method was used to determine the levels of amlodipin, valsartan, and hydrochlorotiazid in tablet preparations by analyzing the absorbance spectra of the samples.

Q: What are the advantages of using the chemometric method in determining levels?

A: The chemometric method has several advantages, including increasing efficiency, increasing sensitivity, and increasing accuracy. It allows simultaneous analysis of various components in a sample, so that the analysis process is faster and more efficient compared to conventional analysis methods.

Q: What are the limitations of the study?

A: The study has several limitations, including:

The study only focused on the determination of amlodipin, valsartan, and hydrochlorotiazid levels in tablet preparations.
The study did not investigate the effect of other factors on the accuracy and precision of the method.
The study did not compare the results of the chemometric method with other analytical methods.

Q: What are the future directions for this research?

A: Future studies can be conducted to:

Investigate the effect of other factors on the accuracy and precision of the chemometric method.
Compare the results of the chemometric method with other analytical methods.
Apply the chemometric method to analyze the combination of other anti-hypertensive drugs available in the form of tablets.

Q: How can the chemometric method be applied in real-world scenarios?

A: The chemometric method can be applied in various real-world scenarios, such as:

Quality control of pharmaceutical preparations
Analysis of complex mixtures
Development of new analytical methods

Q: What are the potential applications of the chemometric method in the pharmaceutical industry?

A: The chemometric method has several potential applications in the pharmaceutical industry, including:

Development of new analytical methods
Quality control of pharmaceutical preparations
Analysis of complex mixtures

Q: How can the chemometric method be used to improve the accuracy and precision of analytical methods?

A: The chemometric method can be used to improve the accuracy and precision of analytical methods by:

Correcting systematic errors
Reducing noise in data
Increasing sensitivity

Q: What are the potential benefits of using the chemometric method in the pharmaceutical industry?

A: The chemometric method has several potential benefits in the pharmaceutical industry, including:

Improved accuracy and precision of analytical methods
Increased efficiency and speed of analysis
Reduced costs and improved quality control

Q: How can the chemometric method be used to analyze complex mixtures?

A: The chemometric method can be used to analyze complex mixtures by:

Using multivariate statistical models to analyze data
Applying various chemometric techniques, such as principal component analysis (PCA) and partial least squares (PLS) regression.

Q: What are the potential applications of the chemometric method in the field of pharmaceutical analysis?

A: The chemometric method has several potential applications in the field of pharmaceutical analysis, including:

Analysis of complex mixtures
Development of new analytical methods
Quality control of pharmaceutical preparations.