Tạp chí Kiểm nghiệm Dược và Mỹ phẩm

Establishment of a reference standard for epimedin C isolated from Herba Epimedii by mass-balance

Nguyễn Lâm Hồng, Lê Thị Trang, Trần Việt Hùng — Mon, 29 Jun 2026 00:00:00 +0000

Herba Epimedii comprises the dried aerial parts of various Epimedium species (family Berberidaceae). This medicinal material is widely recognized for its pharmacological activities, including sexual function enhancement, anti-osteoporotic, cardiovascular protective, anti-inflammatory, antioxidant, and immunomodulatory effects. Epimedin C is a primary bioactive constituent and is mandated as a reference standard for the qualitative and quantitative analysis of Herba Epimedii in the Vietnamese Pharmacopoeia V. Consequently, the development of a cost-effective, domestic Epimedin C reference standard is critical for the rigorous quality control of this botanical drug. In this study, 6.5 g of Epimedin C was isolated and purified from 5 kg of Herba Epimedii raw material. The structural integrity was confirmed via spectroscopic techniques (1H and 13C-NMR, IR) and HPLC-DAD profiling. The chromatographic purity was determined to be 98.2% using the area normalization method at a test concentration of 1.0 mg/mL, while the total volatile content was measured at 5.0% via Thermogravimetric Analysis (TGA). Finally, by applying the mass balance approach to account for all impurities, the label-assigned content for 125 vials of the Epimedin C reference standard was established as 93.3 ± 0.44% (k = 2).

Development and validation of a simultaneous HPLC method for quantification of ketoprofen and methylparaben in topical gel

Mon, 29 Jun 2026 00:00:00 +0000

This study has developed a method for simultaneous quantification of ketoprofen and methylparaben in topical gel by reversed-phase HPLC. The method was performed on a Phenomenex C18 column (4.6 mm × 250 mm; 5 µm), using a mobile phase of acetonitrile – 0.1% ortho phosphoric acid (50 : 50, v/v) under isocratic conditions, at a flow rate of 1.0 mL/min, column temperature 35°C, UV detection at 254 nm, and injection volume of 10 µL. The method was validated for specificity, system suitability, linearity, accuracy, precision (repeatability and intermediate precision) in accordance with ICH Q2(R2) guidelines and AOAC 2016. Validation results demonstrated that the method is suitable for simultaneous determination of ketoprofen and methylparaben in topical gel and can be applied in quality control laboratories.

Establishing a preliminary quality standard for Herba Mimosae Pudicae

Hứa Hoàng Oanh — Mon, 29 Jun 2026 00:00:00 +0000

Mimosa pudica L. (commonly known as “Xấu hổ” in Vietnam) is a widely used medicinal plant and serves as a raw material for various traditional medicine formulations due to its anti-rheumatic and sedative properties. However, the Vietnamese Pharmacopoeia V has not yet established a monograph specifying quality standards for this herbal material. This study aimed to develop an in-house quality standard for Herba Mimosae pudicae, including macroscopic and microscopic characterization (plant anatomy and histology); determination of moisture content; total ash; qualitative identification by thin-layer chromatography (TLC); powder microscopy analysis; acid-insoluble ash; and quantitative determination of the principal active constituent using high-performance liquid chromatography (HPLC). The medicinal material Mimosa pudica L. was characterized in terms of macroscopic and microscopic features. TLC analysis showed spots with identical color and Rf values compared to those of the reference standard. The mimosa content ranged from 264 to 364 µg/g. Quality parameters were established as follows: moisture content < 13%, foreign matter < 1%, and total ash < 8%. This study has preliminarily established a set of in-house quality standards for the medicinal plant Mimosa pudica L.

Isolation, purification and standardzation of raw material of lobetyolin extracted from Radix Codonopsis Javanicae for reference standard establisment

Mon, 29 Jun 2026 00:00:00 +0000

Lobetyolin is a compound widely used as a marker for the quality control of medicinal materials derived from several species of the Codonopsis genus in the monographs of various pharmacopoeias. In Vietnam, research on the establishment of a lobetyolin reference substance remains limited, and such standards are mostly purchased from foreign sources. This study developed an efficient process for the isolation and purification of lobetyolin from Codonopsis javanica using liquid-liquid extraction, normal-phase column chromatography, and preparative reversed-phase HPLC. The overall yield for the isolation and purification process was 24.65%. After purification, the lobetyolin raw material was characterized and standardized using the following parameters: identification via IR and UV-Vis spectroscopy, loss on drying, melting point, specific optical rotation, related substances, and chromatographic purity. The analytical procedure for the determination of related substances and chromatographic purity was fully validated in compliance with ICH and AOAC International guidelines. With a lobetyolin content of 98.96% (w/w), the purified material obtained in this study is suitable for the establishment of a lobetyolin reference substance for quality control purposes.

HPLC fingerprint spectrum analysis of alkaloids in Arecae Semen

Bạch Thị Thắm, Zhu Tao, Ling Jie, Lin Queyue — Mon, 29 Jun 2026 00:00:00 +0000

Arecae Semen, the dried ripe seed of Areca catechu L. (Arecaceae), is an important medicinal material widely used in traditional medicine throughout Vietnam and other Asian countries. Alkaloids are recognized as the characteristic bioactive constituents of Arecae Semen and played a crucial role in its quality evaluation. However, variations in geographical origin and harvest maturity may result in considerable differences in alkaloid composition, leading to inconsistency in the quality of commercial materials. To establish and validate a high-performance liquid chromatography (HPLC) fingerprint method based on characteristic alkaloid constituents for the comprehensive quality evaluation of Arecae Semen samples collected from different cultivation regions in Vietnam. Thirty batches of Arecae Semen samples were collected from major cultivation areas across Vietnam. Chromatographic separation was achieved on a BEH Amide column using gradient elution with acetonitrile and 0.2% phosphoric acid containing 0.2% triethylamine, and UV detection was performed at 210 nm. Four characteristic alkaloids, namely arecoline, guvacoline, arecaidine and guvacine were employed as reference compounds for peak assignment and fingerprint characterization. Similarity analysis was subsequently applied to assess chemical consistency among samples. The validated method demonstrated satisfactory precision, repeatability, and stability, with retention-time RSD values below 3.0%. Most ripe Arecae Semen samples exhibited high fingerprint similarity values (> 0.90), indicating consistent alkaloid profiles, whereas immature samples showed significantly lower similarity values, reflecting substantial variations in alkaloid composition. The combination of chromatographic fingerprinting with four reference alkaloids offers an effective strategy for quality control and may provide a scientific basis for the establishment of future pharmacopoeial standards for Arecae Semen.

Morphological, anatomical and phytochemical profiling of Withania Somnifera (L.) Dunal cultivated in Gia Lai, Vietnam

Nguyễn Thu Ánh, Huỳnh Lợi, Phạm Văn Sơn — Mon, 29 Jun 2026 00:00:00 +0000

Withania somnifera (L.) Dunal is a medicinal species extensively investigated for its pharmacological activities; however, region-specific pharmacognostic data remain limited, particularly for materials cultivated in Southeast Asia. This study aimed to establish a comprehensive diagnostic profile of W. somnifera cultivated in Gia Lai Province, Vietnam, integrating morpho-anatomical and preliminary phytochemical analyses. Macroscopic, anatomical, and powder microscopic characteristics were systematically investigated, alongside preliminary phytochemical screening using a modified Ciuley fractionation approach. The Vietnamese specimens exhibited typical species-specific traits, including pubescent aerial organs, swollen roots, and characteristic orange-red berries. Anatomical analysis revealed abundant calcium oxalate crystals, branched multicellular trichomes, dorsiventral mesophyll organization, and the presence of intraxylary phloem, all of which represent key diagnostic features. Powder microscopy further confirmed the presence of characteristic vessel elements, starch granules, and crystal morphotypes. Phytochemical screening revealed an organ-specific distribution of secondary metabolites, with sterol/triterpenoid-like constituents broadly detected, alkaloids predominant in roots, and carotenoids abundant in leaves and fruits. Flavonoids, saponins, tannins, and cardiac glycosides were distributed across multiple organs. These findings provide a robust set of region-specific diagnostic markers supporting authentication, quality control, and future standardization of Vietnamese-cultivated W. somnifera, thereby contributing valuable data to the global pharmacognostic database.