Development and Validation of HPTLC Fingerprint Method for 16 Homeopathic Mother Tinctures Lacking Standards

IF 1.7 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Biomedical Chromatography Pub Date : 2025-08-19 DOI:10.1002/bmc.70194

Arun Kumar, Amit Pandey, Narendra Kumar Gaur, Sunil Kumar Vishwakarma, Snigdha Suman Dalua, Poorva Tiwari, Ramachandran Valavan

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Abstract

High performance thin layer chromatography (HPTLC) is an important quality control method for homeopathic mother tinctures. Homeopathic Pharmacopoeia of India (HPI) provides standards for thin layer chromatography for many drugs. This study is aimed to develop HPTLC standards for those drugs for which TLC standards are not available in HPI. Sixteen drugs (Abrom. r., Bapt., Cass. fis., Cydo. vul., Dict. alb., Guat. gaum., J. ashok., Lactuc., Laur., Liat., Neg. ame., Olib., Onon. spi., Ruta, Chirata, and Ver. anth.) were identified for which TLC method is not available. The design of experiments (DOE) was formulated to determine solvents in the mobile phase, application quantity and dilution, and spray reagent with different combinations to develop separated chromatograms/fingerprints. The developed mobile phases were (9:10) in 11 out of 16 drugs, (80:10:10) in 2 out of 16 drugs, (40:40:10), (50:35:15), (100:15), and (100:11:11:26) are each in one drug. Spray reagent anisaldehyde was found compatible in 13 out of 16 drugs, and (NP/PEG) was used in 3 out of 16 drugs. Daylight, 254 nm, and 366 nm were used as light sources. HPTLC standards for 16 homeopathic drugs lacking entries in HPI were successfully developed. Continuous development of analytical standards is essential to support quality assurance in homeopathic formulations.

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16种顺势疗法母药缺乏标准的HPTLC指纹图谱方法的建立与验证

高效薄层色谱法（HPTLC）是顺势疗法母酊剂的重要质量控制方法。印度顺势疗法药典（HPI）提供了许多药物的薄层色谱标准。本研究旨在为HPI中没有TLC标准的药物制定HPTLC标准。十六种药物（Abrom）。Bapt r。卡斯。金融中间人。, Cydo。vul。, Dict类型。铝青铜。, Guat。gaum。J.震惊。, Lactuc。, Laur。Liat。,底片。ame。,。, Onon。spi。， Ruta， Chirata和Ver。)，而薄层色谱法无法鉴别。制定实验设计（DOE），确定流动相溶剂、用量和稀释度，并以不同组合喷射试剂建立分离色谱/指纹图谱。16种药物中有11种的流动相为（9:10），2种的流动相为（80:10:10），一种药物的流动相分别为（40:40:10）、（50:35:15）、（100:15）和（100:11:11:26）。16种药物中有13种与喷雾试剂茴香醛相容，16种药物中有3种使用（NP/PEG）。光源采用日光，254 nm和366 nm。成功制定了16种HPI中缺少条目的顺势疗法药物的HPTLC标准。分析标准的持续发展对于支持顺势疗法配方的质量保证至关重要。

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.