研究目的
The aim of this research is to use ultra-violet-visible spectroscopy along with chemometrics procedure to simultaneously quantitative analysis of indomethacin (IMC) and benzoic acid (BA) in the gel during pharmaceutical manufacturing process.
研究成果
The UV-VIS spectrophotometric method combined with PLS chemometrics successfully enabled simultaneous quantitative analysis of IMC and BA in gels, demonstrating linear relationships and accurate predictions. It proved effective for real-time monitoring during manufacturing, with the centrifugal mixer achieving homogeneity faster than the conventional mixer. This approach offers a simple, cost-effective alternative to traditional methods, with potential for automation and broader application in pharmaceutical process analytical technology.
研究不足
The method requires sample dilution, which adds steps to the process. The UV-VIS spectra have overlapping peaks, which complicates analysis without chemometrics. The calibration models may be sensitive to high absorbance values above the linear range of the detector, potentially increasing measurement errors. The study is limited to specific gel formulations and may not generalize to other semi-solid dosage forms without adaptation.
1：Experimental Design and Method Selection:
The study used UV-VIS spectrophotometry combined with chemometrics (partial least squares regression, PLS) for simultaneous quantitative analysis of IMC and BA in gel formulations. Calibration models were developed using PLS with various pre-treatments (e.g., non-treatment, derivatives, normalization) to handle overlapping spectra.
2：Sample Selection and Data Sources:
Gel samples were prepared with varying concentrations of IMC (0.1–1.5%) and BA (0.015–0.225%), along with 2% Carbopol? 941 and 95% ethanol. A total of 22 formulations were used for calibration and validation, with spectra recorded for each sample.
3：1–5%) and BA (015–225%), along with 2% Carbopol? 941 and 95% ethanol. A total of 22 formulations were used for calibration and validation, with spectra recorded for each sample.
List of Experimental Equipment and Materials:
3. List of Experimental Equipment and Materials: Materials included IMC (Tokyo Chemical Industry), Carbopol? 941NF (Lubrizol Advanced Material), BA and ethanol (Wako Pure Chemical Industry). Equipment included a UV-VIS spectrophotometer (UV2550, Shimadzu), planetary centrifugal mixer (Thinky Mixer AR-100, Thinky Co. Ltd.), magnetic stirrer, and software (Pirouette version 4.5, Infometrix).
4：5, Infometrix).
Experimental Procedures and Operational Workflow:
4. Experimental Procedures and Operational Workflow: Gels were prepared by mixing ingredients using a planetary centrifugal mixer or magnetic stirrer. Samples were taken at specific time points, diluted 20 times with ethanol, and scanned using the UV-VIS spectrophotometer over 200–450 nm. Spectra were processed using PLS in Pirouette software to build and validate calibration models.
5：Data Analysis Methods:
PLS regression was applied to the spectral data with leave-one-out cross-validation to determine standard errors (SEV, SEC, SEP) and correlation coefficients (r). Best models were selected based on minimal error and high correlation.
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