RÉSUMÉ
Sofosbuvir is an antiviral drug that is used to treat hepatitis C. A present investigation deals with simple, sensitive, rapid, precise and accurate reverse phase high-performance chromatography (RP-HPLC) method developed and validated for related substances of sofosbuvir in tablet dosage form. The chromatographic separation was achieved on a Kromasil 100 C18 (250 × 4.6 mm, 5 ?) column. A sofosbuvir and its impurities were extracted by composed mixture of Mobile Phase A: buffer solution: acetonitrile (97.5:2.5% v/v) and Mobile Phase B: acetonitrile, isopropyl alcohol, methanol and purified water (60:20:10:10 % v/v/v/v) using with flow rate was 1-mL/min, column temperature was 25°C, injection volume was 10 ?L, Vial thermostat temperature was 10°C. The UV detection was carried out at 263 nm. The retention time of sofosbuvir, methyl ester and ethyl ester were 54.28, 36.31 and 43.77, respectively. The method shows linearity with correlation coefficient of sofosbuvir and its impurity was 0.999 over the 0.5–7.5 ppm range. The average recovery was found to be 90.2–113.9%. The LoD and LoQ for sofosbuvir and its impurities were found to be 0.1 and 0.5 ?g/mL, respectively. The method was validated as per ICH guidelines. The developed method was precise, accurate, novel and detectable towards sofosbuvir and its impurity. This method is efficient in separating the sofosbuvir and its impurity. Hence, the proposed method can be utilized for the determination of related substances in routine analysis in quality control department of pharmaceutical Industry.
RÉSUMÉ
Oryza sativa L. indica (black rice) has a rich cultural history and used as a tribute food. As the outer layer of seeds contains anthocyanin, O. sativa L. indica is black. Traditionally the plant used to enhance heart health, reduces the risk of atherosclerosis, diabetes as well as allergy, control hypertension, and improves the digestive system and lipid profile. It has anti-inflammatory action, detoxifies the body, decreases cancer growth, supports in weight management, and improve memory and quality of life. Here, the methanolic extract of black rice (BRME) was evaluated for its anti-anemic effect. In study anemia was induced by administering 40 mg/kg phenylhydrazine (PHZ) for two consecutive days in rats. From day 3, animals were treated with standard drug and BRME extracts (200 and 400 mg/kg) till 15 days. The anti-anemic activity was examined by estimating different parameters like hemoglobin, red blood cell, hematocrit, reticulocytes, aspartate amino transaminase activity, alanine amino transaminase and alkaline phosphatase. The results of the phytochemical test revealed the presence of carbohydrates, alkaloids, glycosides, saponins, flavonoids, tannins, amino acid, and triterpenoids. Methanolic extract of black rice also restored the hematological parameter and biochemical parameters values near to normal levels after 13 days of treatment at 200 and 400 mg/kg. The 400 mg/kg dose shows higher anti-anemic effect compared to the lower 200 mg/kg dose. From the result, it is concluded that O. sativa L. indica is a valuable source of active compounds with anti-anemic properties and can be used to treat anemia.