Spectrophotometric Methodologies Applied for Determination of Pharmaceuticals

Cini, Nejla; Gölcü, Ayşegül; Fatma, Ağin; Sze, Yuen Lew; Seong, Lin Teoh; Siew, Huah Lim; Lee, Wei Lim; Kah, Hui Wong; Jangra, Surender; Pothuraju, Ramesh; Raj, K S Bimal; Gaurav, Bhakri; Pankaj, K.; Garg, Varun; Mittal, Neeraj; Huai-Chuan, Duan; Peng, Lianxin; Hu, Yichen; Luo, Qing; Liu, Xinyu; Sun, Xin; Liang, Li; Ya, Gan; Liu, Wei; Hua, Wan Ming; Hu-Bing, Shi; Zhao, Gang; Hu, Jianping; Xiuyu, Qian; Li-xing, Nie; Dai, Zhong; Shuang-cheng, MA; Izat, Nihan; Kaplan, Ozan; Çelebi̇er, Mustafa; Şahin, Selma; Chen, Lexing; Li, Shiying; Jiang, Liu; Xia, Gan; Zhounan, Jiang; Xu, Jun; Shaohui, Cai; Padhi, Somanath; Mazumder, Rupa; Shradha, Bisth

doi:10.2174/1573411016999200526133357

Cited by 6 publications

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“…Additionally, acidification of the reaction mixtures with dilute mineral acid (HCl) did not cause fading of the solutions' colors. This observation revealed that the reaction proceeded via irreversible covalent bonding, rather than the possible irreversible charge-transfer reaction between CER, as an electron donor, and the reagents (CHL, BRL, and DCNQ), as electron acceptors [29].…”

Section: Absorption Spectra and Reaction Stoichiometrymentioning

confidence: 95%

Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing

Abuhejail,

Alzoman,

Darwish

2023

Molecules

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Ceritinib (CER) is a potent drug that has been recently approved by the Food and Drug Administration for the treatment of patients with non-small cell lung cancer harboring the anaplastic lymphoma kinase mutation gene. The existing methods for the quality control of CER are very limited and suffer from limited analytical throughput and do not meet the requirements of the green analytical principles. This study presented the first-ever development and validation of three innovative green and high-throughput microwell spectrophotometric methods (MW-SPMs) for the quality control of CER in its dosage form (Zykadia® capsules). These MW-SPMs were based on the formation of colored N-vinylamino-substituted haloquinone derivatives of CER upon its reactions with each of chloranil, bromanil, and 2,3-dichloro-1,4-naphthoquinone in the presence of acetaldehyde. The optimized procedures of the MW-SPMs were established, and their analytical performances were validated according to the ICH. The linear range of the MW-SPMs was 5–150 µg/mL, with limits of quantitation of 5.3–7.6 µg/mL. The accuracy and precision of the MW-SPMs were proved, as the average recovery values were 99.9–101.0%, and the relative standard deviations did not exceed 1.8%. The three methods were applied to the determination of CER content in Zykadia® capsules and drug content uniformity testing. The greenness of the MW-SPMs was proved using three different metric tools. In addition, these methods encompassed the advantage of high-throughput analysis. In conclusion, the three methods are valuable tools for convenient and reliable application in the pharmaceutical quality control units for CER-containing capsules.

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Section: Absorption Spectra and Reaction Stoichiometrymentioning

confidence: 95%

Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing

Abuhejail,

Alzoman,

Darwish

2023

Molecules

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“…This technique sometimes requires the analysis of the spectrum at many wavelengths. Currently, the ratio spectra derivative method makes selecting a measurement wavelength easy and avoids using the zero-crossing technique to read the derivative result [32,33].…”

Section: Open Accessmentioning

confidence: 99%

Simultaneous spectrophotometric determination of finasteride and tadalafil in recently FDA approved Entadfi™ capsules

Abdelazim

Ramzy

2022

BMC Chemistry

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Entadfi™ is a recently FDA approved pharmaceutical combination capsule of finasteride and tadalafil. It was prescribed for the treatment of urinary tract disorders caused by benign prostatic hyperplasia in men. This paper introduced the first spectrophotometric methods for simultaneous determination of finasteride and tadalafil in the pure form and in the pharmaceutical capsules. UV absorption spectra of finasteride and tadalafil exhibited overlap hindered the direct simultaneous determination of the cited drugs. The UV absorption spectra of finasteride and tadalafil were transformed to the second order derivative. Finasteride could be determined selectively at 230.80 nm without interference from tadalafil. Moreover, tadalafil could be determined selectively at 292 nm without interference from finasteride. The ratio spectra of the studied drugs were derived and the derived ratio spectra of each drug were transformed to the first order derivative. Finasteride could be determined selectively at 218.80 nm without interference from tadalafil. Moreover, tadalafil could be determined selectively at 289.60 nm without interference from finasteride. The methods showed linearity with an excellent correlation coefficient in the concentration range of 10–140 µg/mL for finasteride and 3–40 µg/mL for tadalafil. The methods were validated following ICH guidelines for accuracy, precision, robustness, limit of detection, limit of quantification, and selectivity. The methods were found to be sensitive with LOD values for finasteride and tadalafil of 2.406 µg/mL and 0.876 µg/mL using the second derivative with zero crossing method and 2.229 µg/mL and 0.815 µg/mL using the first derivative of ratio spectra method. The methods were successfully applied for the determination of the studied drugs in their laboratory prepared mixtures, with mean percent recovery for finasteride and tadalafil of 99.37% and 99.17% using the second derivative with zero crossing method and 99.74% and 99.56% using the first derivative of ratio spectra method. Furthermore, the described methods were successfully applied for determination of the studied drugs in Entadfi™ capsules without interference from excipients. Based on the proposed results, the described methods could be utilized as simple method for the quality control of the studied drugs.

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“…To overcome these limitations of FIA, Ruzicka and Marshall introduced sequential injection analysis (SIA) in 1990 as an alternative flow-through sample-handling and sensing technique which is economical with respect to both sample and reagent consumption in addition to allowing computer control of most manifold and operational parameters [ 13 ]. This flow technique has been successfully applied to the analysis of analytes of pharmaceutical interest [ 14 , 15 , 16 , 17 ]. Since the reagents for the spectrophotometric determination of NACET mentioned above (i.e., NCN, BCA, and BCS) are expensive (e.g., €146 per gram of BCS, Sigma-Aldrich, Burlington, MA, USA), SIA is expected to reduce significantly the cost of analysis compared to FIA.…”

Section: Introductionmentioning

confidence: 99%

Determination of N-Acetyl-L-cysteine Ethyl Ester (NACET) by Sequential Injection Analysis

Kukoc-Modun,

Kraljevic,

Tsikas

et al. 2024

Sensors

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New sequential injection analysis (SIA) methods with optical sensing for the determination of N-acetyl-L-cysteine ethyl ester (NACET) have been developed and optimized. NACET is a potential drug and antioxidant with advantageous pharmacokinetics. The methods involve the reduction of Cu(II) in its complexes with neocuproine (NCN), bicinchoninic acid (BCA), and bathocuproine disulfonic acid (BCS) to the corresponding chromophoric Cu(I) complexes by the analyte. The absorbance of the Cu(I) complexes with NCN, BCA, and BCS was measured at their maximum absorbance wavelengths of 458, 562, and 483 nm, respectively. The sensing manifold parameters and experimental conditions were optimized for each of the Cu(II) complexes used. Under optimal conditions, the corresponding linear calibration ranges, limits of detection, and sampling rates were 8.0 × 10−6–2.0 × 10−4 mol L−1, 5.5 × 10−6 mol L−1, and 60 h−1 for NCN; 6.0 × 10−6–1.0 × 10−4 mol L−1, 5.2 × 10−6 mol L−1, and 60 h−1 for BCA; and 4.0 × 10−6–1.0 × 10−4 mol L−1, 2.6 × 10−6 mol L−1, and 78 h−1 for BCS. The Cu(II)-BCS complex was found to be best performing in terms of sensitivity and sampling rate. Usual excipients in pharmaceutical preparations did not interfere with NACET analysis.

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Spectrophotometric Methodologies Applied for Determination of Pharmaceuticals

Cited by 6 publications

References 0 publications

Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing

Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing

Simultaneous spectrophotometric determination of finasteride and tadalafil in recently FDA approved Entadfi™ capsules

Determination of N-Acetyl-L-cysteine Ethyl Ester (NACET) by Sequential Injection Analysis

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