The vitamin D or so-called “sunshine” vitamin is hot topic currently because of the COVID-19 pandemic and the confirmed relationship between the vitamin D blood levels and disease severity among COVID-19 patients. The topic is of upmost importance also because a considerable percentage of the worldwide population is deficient in this essential nutrient. A recent study showed that 80% of Slovenians lack vitamin D3 as well.
Vitamin D exists in various forms but the most physiologically relevant are vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). Due to the insufficient endogenous synthesis by sunlight exposure, vitamin D is usually supplemented through food supplements in forms of capsules, tablets, drops, liposomic solutions or other dosage form. The vitamin D present in food supplements is mainly in form of vitamin D3, while vitamin D2 is less common.
Vitamin D3 in food supplements can be found in formulations with single active ingredient or in combination with various active ingredients due to its synergistic effect such as combinations with Ca and vitamin K2 for bone and cardiovascular health, in multivitamin combinations or together with immune-supporting ingredients like beta-glucan, royal jelly etc. The concentrations of vitamin D3 in food supplements or fortified foods can be found in wide range starting from 1 µg (40 IU) to 100 µg (4000 IU) per dosage. Generally, food supplements formulations are very complex and beside active ingredients contain various excipients or inactive substances such as lipophilic solvents, emulsifiers, colouring agents, preservatives, fillers etc.
One of the most important challenges of vitamin D3 quantification is the presence of various interferences from the sample matrix because a large number of lipophilic compounds are co-extracted during sample preparation and numerous co-elutions may interfere with the vitamin D3 quantification.
Accurate analysis of vitamin D3 is also critical because vitamin D3 is susceptible to degradation by heat, oxygen, light, humidity and acidic conditions. Therefore, routine testing by stability indicating methods is required to verify that the nutrient is not decomposed during the proposed shelf-life under prescribed storage conditions.
A recent study showed that the shelf life after opening of the examined prescription medicines containing vitamin D3, as main active ingredient, is at least 1 year at room temperature after opening. Similarly, food supplements must be tested to ensure appropriate dosage of the vitamin D3 in order to prevent the symptoms of deficiency and on the other hand, the side effects in case where the declared content substantially exceeds declarations.
It is well known that due to potential overages to cover losses during production and shelf-life, the actual vitamin D3 content in fortified foods and food supplements may deviate from the label. The published results showed that determined vitamin D3 content, compared to the declared values, ranged from 50% to 153% for fortified foods and from 8% to 177% for supplements and may reach up to 200%.
Such results are not only concerning but also reveal the need for stricter regulation and quality control of the food supplements on the market.
Therefore, measurement of vitamin D3 content represents an important quality aspect and each food supplement requires customised analytical approach in both sample preparation and analysis due to the complexity of the matrices in order to deliver reliable results that will reflect the real content of the active ingredient considering the declared amount.
HPLC-UV is widely recognized technique for identification and quantification of the active ingredients in various formulations. However, often, quantification of vitamin D3 in some formulations requires employment of more specific and sensitive techniques such as mass detection because of the relatively low content of vitamin D3 in such formulations and the existing co-elutions from other lipophilic ingredients present in the formulations.
Consequently, appropriate analysis of vitamin D3 in foodstuffs is time consuming, labour and equipment extensive and requires experienced analysts as well as extreme attention to details in order to deliver reliable and quality results.
Routine in-house content controls during product development and after launching allows monitoring of the ingredient levels in the formulations available on the market, guarantees quality and builds trust among consumers.
Our laboratory is specialized for method development, validation and employment of validated methods for accurate quantification of the active ingredients in various food supplements. We would be pleased to carry out the analysis for you and to provide quick, competent and reliable support.
INSLAB’s experts are routinely performing vitamin D3 analysis in raw materials, oral solutions, syrups, capsules, tablets and other food supplements by both UHPLC-UV and UHPLC-MS technique.
In addition, our contract laboratory can assist you with food supplements and nutraceuticals lab expertise, knowledge and support services during product development and launching in order to deliver products with proven quality and safety.
For more information about dietary supplements analysis contact us: info@inslab.si
INSLAB is laboratory that provides customised services to the clients that develop and manufacture food supplements and related products.With our services you will advance your product development process and achieve competitive advantage by offering products with scientifically supported data, improved formulations and product stability.
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Tags: food supplement, vitamin D3