ABSTRACT

The objective of the study was to develop and evaluate the reverse phase high performance liquid chromatography (RP-HPLC) method for the quantitative determination of potential impurities of Mirabegron active pharmaceutical ingredient. The method uses Puratis C18 column (250 × 4.6mm, 5µm ) with mobile phase A consisted, 20 mM Ammonium acetate, pH adjusted to 4.5 and mobile phase B consisted methanol  with a gradient programme. The column temperature was maintained at 25 ^°C and the detection was carried out at 247 nm. Efficient and reproducible chromatographic separation was achieved on C₁₈ stationary phase in gradient elution profile. The newly developed HPLC method was validated according to ICH guidelines considering three impurities to demonstrate precision, linearity, accuracy and robustness of the method. The developed HPLC method was found to be accurate and sensitive. The correlation coefficient values are greater than 0.99 for Mirabegron and its three impurities. Detection limit and quantitation limit was 0.04ppm and 0.14ppm respectively, indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 99.67% and 104.98% for all impurities. The result of robustness study also indicates that the method is robust and is unaffected by small variation in chromatographic conditions. The proposed HPLC method provides reliable, reproducible, accurate and sensitive for the quantification of Mirabegron related substances.

Keywords: Mirabegron; Impurities; RP-HPLC; Validation.

ABSTRACT

With increasing incidences of side effects and adverse drug reactions, the consumer choices are more inclining towards natural products and medicines obtained from natural sources. One such emerging class of products are 'Nutraceuticals'. Nutraceutical is a compound defined as food or parts of a food having health benefits and helps in prevention and treatment of diseases. It includes isolated nutrients, dietary supplements, herbal products and processed foods. Nowadays Nutraceuticals are preferred for providing additional health benefits and for prevention and treatment of diseases due to its safety, potential and therapeutic efficacy. Nutraceuticals have advantage over the drugs or medicines because they are naturally found dietary supplements and don’t have side effects .These are classified into three categories which are Nutrients , Herbals and Dietary supplements .Nowadays, sedentary and passive lifestyles have become common causes of many diseases related to lifestyle, metabolism, weight-related disorders, cardiovascular disorders etc. The incidence of cardio-vascular diseases have been increasing since decades throughout the world. Studies show that India is the highest contributor to the number of cases of cardiovascular diseases. Cardio Vascular Diseases (CVD) are the most common health problem faced by the populations it may be fatal at later stages. Recent studies have shown that cardiovascular risk factors like obesity, diabetes, hypertension are highly prevalent even in younger generations. Various Nutraceuticals are used for the prevention and treatment of CVD or to reduce the risk factors which leads to CVD , these risk factors are Atherosclerosis, Dyslipidemia , Hypertension , Diabetes Mellitus . Commonly known Nutraceuticals used to treat CVD or reducing its risk factors are Berberine , ?-glucans , Polyphenols , Plant sterols or stanols and these are widely found in plants , foods and food products from plant origin , vegetables , cereals , fruits , legumes .

Keywords: Nutraceuticals, polyphenols, sterols, Cardiovascular diseases (CVD).