Development of a Validated HPTLC-dual wavelengths Method for Simultaneous Determination of Yohimbine, Caffeine, Niacin and Alpha-tocopheryl succcinate in their Challenging Quaternary Mixture

Abdelgawad Hammam, Dina Ahmed; Youssef, Rasha Mostafa; Hassan, Ekram Mahmoud; Abdelhafez, Aya Mohamed

doi:10.21608/japs.2024.334707.1031

Development of a Validated HPTLC-dual wavelengths Method for Simultaneous Determination of Yohimbine, Caffeine, Niacin and Alpha-tocopheryl succcinate in their Challenging Quaternary Mixture

Document Type : Original Article

Authors

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt

10.21608/japs.2024.334707.1031

Abstract

Millions of men throughout the world are endangered by erectile dysfunction (ED). Diabetes, vascular disease, neurological disorders, or prostate-related medications can all lead to ED. Sometimes it is as simple as the side effect of a specific treatment. However, the reason is more complicated for 75% of men. The treatment for ED could include certain prescription medications, lifestyle changes, and other natural treatments. Yohimbine (YB) is an indole alkaloid derived from Central African yohimbe tree bark that is widely used as therapy for ED. In the Egyptian market, YB has been formulated as capsules in combination with Caffeine (CF), Niacin (NA) and Alpha-tocopherol succinate (ES). This quaternary mixture is effectively used for treatment of ED and other associated disorders like fatigue, heart attack, leg pain due to blocked arteries and vitamin B3 deficiency. So, it seems necessary to develop selective analytical technique for assay of this multi-combination. In the proposed study, validated HPTLC technique was developed for concurrent determination of YB, CF, NA and ES, formulated in Super act® capsules.
The suggested method depends on HPTLC segregation of the drugs at 270 nm for YB, CF, NA and at 280 nm for ES. Separation was accomplished on silica gel 60 F254 aluminum sheets, produced by Merck, using chloroform: methanol (9.8:0.2 v/v) as mobile phase. The method was found linear in the range of 0.8-6, 0.8-10, 0.4-6 and 6-14 ug /band-1 for YB, CF, NA and ES, respectively. The reported chromatographic method performed well in terms of linearity, sensitivity, precision, accuracy, and stability after undergoing validation in accordance with ICH guidelines. Using the F and t-test as statistical methods, it was effectively utilized to analyze quaternary mixtures in dosage form, and the outcomes showed good compliance with those from the comparison method.

Highlights

• Yohimbine was formulated in combination with Caffeine, Niacin and Alpha-tocopherol succinate for treatment of Erectile dysfunction.
• The proposed dual-wavelength HPTLC method was developed for simultaneous determination of the four drugs.
• The proposed chromatographic approach showed good performance according to ICH validation.
• It was successfully applied to the analysis of quaternary mixture in dosage form.

Keywords

Main Subjects

Pharmaceutical Analytical Chemistry

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