The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy.

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Current pharmaceutical design Pub Date : 2025-05-05 DOI:10.2174/0113816128355113250414043255

Iqra Naheed, Maida Ehsan, Haq Nawaz, Muhammad Irfan Majeed, Abdulrahman Alshammari, Norah A Albekairi, Arslan Ali, Tehseen Ijaz, Ayesha Saif, Haseeb Akbar, Aleena Aziz, Rida Fatima

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引用次数: 0

Abstract

Objective: This study explores the application of Raman spectroscopy for identifying and quantifying itopride in solid dosage forms with varying concentrations of active ingredients and excipients. Raman spectroscopy provides a non-invasive, rapid, and accurate detection method that is ideal for pharmaceutical analysis.

Method: The Raman spectral features of itopride in solid dosage forms were analyzed using Principal Component Analysis (PCA) and Partial Least Squares Regression Analysis (PLS-RA) as multivariate data analysis techniques.

Results: PCA effectively distinguished Raman spectral data of various itopride drug samples. PLS-RA facilitated quantitative analysis, yielding an R2 value of 0.999%, indicating an excellent explanation of model variability. The root mean square error of calibration and prediction were 0.23 mg and 3.02 mg, respectively. Furthermore, PLS-RA accurately determined the active pharmaceutical ingredient concentration in unknown formulations, with a calculated concentration of 79.66/80 mg (w/w) compared to the actual concentration of 80/140 mg (w/w).

Conclusion: These findings demonstrated that the concentration of itopride in pharmaceutical samples using an established Partial Least Squares Regression calibration model can be determined with reliability.

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拉曼光谱法定量分析依托必利固体剂型。

目的：探讨拉曼光谱在不同活性成分和辅料含量的固体剂型中依托必利的鉴别和定量中的应用。拉曼光谱提供了一种非侵入性，快速，准确的检测方法，是理想的药物分析。方法：采用主成分分析（PCA）和偏最小二乘回归分析（PLS-RA）作为多变量数据分析技术，对依托必利固体剂型的拉曼光谱特征进行分析。结果：主成分分析法能有效区分不同依托必利药物样品的拉曼光谱数据。PLS-RA有助于定量分析，R2值为0.999%，表明模型变异的解释很好。校准和预测的均方根误差分别为0.23 mg和3.02 mg。PLS-RA准确测定了未知制剂中有效成分的浓度，计算浓度为79.66/80 mg (w/w)，而实际浓度为80/140 mg （w/w）。结论：建立的偏最小二乘回归校正模型可可靠地测定药物样品中依托必利的浓度。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current pharmaceutical design 医学-药学

CiteScore

6.30

自引率

0.00%

发文量

302

审稿时长

2 months

期刊介绍： Current Pharmaceutical Design publishes timely in-depth reviews and research articles from leading pharmaceutical researchers in the field, covering all aspects of current research in rational drug design. Each issue is devoted to a single major therapeutic area guest edited by an acknowledged authority in the field. Each thematic issue of Current Pharmaceutical Design covers all subject areas of major importance to modern drug design including: medicinal chemistry, pharmacology, drug targets and disease mechanism.