Chromatographic Characterization on Flavonoids and Triterpenes of Leaves and Flowers of 15 Crataegus L. Species The Hawthorn (Crataegus L.) is the most commonly used herb for treating cardiovascular diseases. The purpose of this paper was the analysis and comparison of HPTLC chromatographic profiles of flavonoids and triterpenes of leaves and flowers of 15 Crataegus L. species occurring throughout Eurasia and North America, and determination of specific distinguishing markers of its fingerprints. The optimal chromatographical conditions for evaluation of flavonoids and triterpenes of 15 Hawthorn species were proposed, the specific HPTLC fingerprints were obtained. The flavonoids fingerprints were qualitatively much the same for the pharmacopoeial species C.laevigata/oxyacantha and C.monogyna and other related non-pharmacopoeial European and Asian Hawthorn species including C.curvisepala, C.pseudokyrtostyla, C.fallacina, C.leiomonogyna, C.ambigua, C.sanguinea, C.almaatensis, C.turkestanica. The specific distinctive features for Hawthorn species native to North America, including C.punctata var aurea, C.pringlei, C.festiva, C.douglasii and C.holmesiana, were determined. The evaluation of the triterpenes profiles showed that all 15 analyzed Hawthorn species had quite similar fingerprints.

Formulations and in-pharmacy preparation process of compounded drugs were being created for centuries, and seem to have no concerns regarding the quality, compatibility and stability during storage or usage. Taking in mind modern trends for quality assurance and standardization of drugs, quality of preparation process of compounded drugs can be proved by using of a systematic approach that is based on pharmaceutical quality systems. Variability of preparation conditions, preparation equipment from pharmacy to pharmacy, personal professional skills require the development of defined standards, rules and summarized the strategy of quality assurance of compounded drugs. The aim of this paper was determination of critical factors and development of the design for quality assurance of compounded drugs. The materials of this study were the regulative base of Ukraine, international documents, guidances and own investigations concerning the requirements for the preparation process and quality control of compounded drugs. The methods used were data systematical analysis, bibliosemantic and summary. The achievement of good quality of compounded drugs can be present as a step-by-step process, that cover adherence to necessary preparation procedure and knowledge of peculiarities of drugs, process understanding, identification of risks and its evaluation, minimization and implementation of the quality management system for documentation, equipment and personnel. As a result of preparation schemes analysis, the critical factors were determined and the Fishbone diagram was proposed. The factors contributing to the general strategy of compounded drugs quality assurance, such as prescription analysis, personnel, regulative base, conditions of preparation process and equipment, documentation, dispensing, characteristics of active ingredients and additives, compounding design, preparation technology, containers and package, quality control, stability and labelling were determined. The proposed diagram of causes and effects can be used as a template for the identification and quantification of risks during preparation and quality control of compounded drugs. The proposed general scheme for quality assurance is necessary for organization and optimization of monitoring preparation and quality control, implementation of remedial and preventive measures, tracking of causes, nonconformities, and prevention of its repetition, management of variables, determination of improvement possibilities and audit conducting.

Authentication of Rhodiola rosea, Rhodiola quadrifida and Rhodiola rosea liquid extract from the Ukrainian market using HPTLC chromatographic profiles Rhodiola rosea and Rhodiola quadrifida are widely distributed and sold in Eastern Europe. The purpose of this paper was to identify R.rosea, R.quadrifida and Rhodiola rosea liquid extract (RRLE) in the Ukrainian market and bring out adulteration cases using chromatographic characterisation by HPTLC. The multiple samples of R.rosea, R.quadrifida and RRLE were compared; the optimal chromatographic conditions for identification of R.rosea and RRLE based on the presence of rosavins and salidroside as well as for identification of R.quadrifida based on the presence of salidroside were proposed; the specific HPTLC fingerprints were obtained; the acceptance criteria for each product were set. The adulteration cases for R.rosea and RRLE samples were established. The dependence on handling R.rosea and presence of rosavins was determined. It was assumed that low-quality raw materials or inefficient technology process were used for RRLE. The consistency of HPTLC fingerprints for R.quadrifida samples was established.

The plants from the Lamiaceae family are traditional remedies of folk and scientific medicine. They are present at the domestic pharmaceutical market as herbal raw material (HRM); dietary supplements; aromatherapy; as well as being included in the composition of drugs for oral use etc. According to the modern direction of international harmonization of conditions for standardizations of herbal drugs, the topical issue is the development of unified methods of HPTLC identification for HRM, including the Lamiaceae family. The aim of the work was the selection of the unified HPTLC chromatographic conditions for identification of chromatographic profiles of flavonoids and hydroxycinnamic acids of HRM of some Lamiaceae species of Ukraine’s flora, presented at domestic pharmaceutical market, such as Sage, Wild Thyme, Thyme, Oregano, Rosemary, Java tea, Peppermint, Lavender, Anise hyssop, Melissa, Hyssop, White horehound, Motherwort; and comparison of their chromatographic fingerprints. As objects of investigation, the HRM of Lamiaceae family presented at the Ukrainian pharmaceutical market were used. The investigation was conducted by HPTLC procedure using an automatic herbal system of CAMAG, Switzerland at the base of CAMAG laboratory, Muttenz, Switzerland and laboratory of ESTCCTI ESIPP, NUPh, Kharkiv, Ukraine. The harmonized chromatographic conditions for determination of flavonoids and hydroxycinnamic acids for HRM of Lamiaceae species were chosen, these were: stationary phase – HPTLC Si 60 F254; mobile phase – ethyl acetate, formic acid anhydrous, water (8:1:1); sample preparation: solvent – methanol; method of extraction – shaking for 10 min; relative humidity: 33%, temperature 22 ± 5 °C; derivatization with Natural product and PEG reagents; detection – 254 nm, 366 nm, white light before derivatization: 366 nm and white light after derivatization. The reproducibility of results in these chromatographic conditions was ∆RF ≤ 0,05. It was established, that for all investigated species of the family the zone corresponding with the position and colour to rosmarinic acid was detected, thus it can be used as standard substance for «Identification», «Limit-test» and for chromatographic system suitability test. For investigated samples of domestic HRM, the specific zones that can be used for setting acceptance criteria of the «Identification» and «Foreign matters» tests were conducted. After validation investigation involving greater numbers of samples of each species from different growing regions of Ukraine, the obtained HPTLC chromatographic fingerprints could be recommended as reference images for quality control of home-grown HRM of Lamiaceae family.

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