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Background: Diabetes Mellitus is a chronic disorder characterised by abnormally elevated glucose levels in the blood. Diabetes is caused by one of two mechanisms: insufficient insulin synthesis (which is produced by the pancreas and reduces blood glucose) or insufficient response of cells to insulin action. The current aim of this research project was to formulate and evaluate the Polyherbal preparation (PHP) of the plants constituted with Cinnamonum zeylanicium (CJ) bark, Eugenia jambolana (EJ) seeds, Vinca rosea (VR) whole plant, Gymnema sylvestre (GS) leaves and determination of the anti-diabetic potential of the formulation in the animal model induced by Streptozotocin. Methods: Plant components in the current study used were Cinnamonum zeylanicium (CJ) bark, Eugenia jambolana (EJ) seeds, Vinca rosea (VR) whole plant, Gymnema sylvestre (GS) leaves were collected.Using a hydroalcoholic solvent, physico-chemical parameters and active chemical constituents were evaluated. The active components present in the extracts were identified by Preliminary phytochemical screening. The PHP acute toxicity analysis was conducted in compliance with OECD Guideline 423, with 200 mg/kg and 4000 mg/kg administered orally to rats over 28 days. Results: Diabetes was induced by STZ and treated with PHF did not show any alterations in behavior and no mortality was observed up to the 2000 mg/kg dose level during the interventional period. By oral administration of PHP with a dosage of 200 and 400 mg/kg, OGTT resulted in a steady decrease in blood glucose levels of 68.74±4.63 mg/dl and 63.83±1.74 mg/dl at 180min after the trial which proves that PHP possess anti-diabetic activity. By mixing each extract in varying proportions, PHP was developed and evaluated. PHP (200 and 400mg/kg) antidiabetic activity wasdetermined for streptozotocin (STZ)-induced diabetes in rats and glibenclamide (5.0mg/kg body weight) was used as a standard drug.The investigational drug was administered for 28 days and the blood glucose level effect of the PHP was analysed on the 28th day after the intervention time. Conclusion: The experimental study showed that a persistent and substantial decrease in the average blood glucose level of diabetic rats was observed with repeated administration of PHP and glibenclamide for 28 days. PHP demonstrated substantial antidiabetic and antihyperlipidemic activity similar to the standard drug. The formulation will emerge as a possible mixture that may challenge the synthetic drug.

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A simple, precise and reproducible RP-HPLC method was developed for the estimation of related substances in tilorone dihydrochloride. Quantification was performed using a Zorbax SB-phenyl column (150 × 4.6mm, 5µ) with mobile phase A: 20mM potassium dihydro phosphate + 2ml of triethylamine, pH 2.30 and mobile phase B: acetonitrile, methanol and water 60: 20: 20% v/v. A gradient program was followed with a run time of 55 minutes at a flow rate of 1.0 ml/min. The column temperature was maintained at 40°C, the injection volume was 10 µl and the detection was performed at 269nm using a PDA detector. The retention time of Tilorone dihydrochloride was found to be 10.36 minutes. The proposed method has been validated according to the ICH guidelines for Linearity, Precision, Accuracy, LOD, and LOQ. The method was linear from 0.157 - 3.934μg/ml for standard, 0.153-3.820μg/ml and 0.166 - 4.140μg/ml for impurities, TLHC01 and TLHC02 respectively. The impurities TLHC01 and TLHC02 have been mapped in all stress conditions. The LOD and LOQ of TLHC01 were found at 1.757μg/ml and 5.857μg/ml and 1.919μg/ml and 6.396μg/ml respectively for TLHC02 respectively. Statistical analysis showed that the method was precision, reproducible, selective, specific and accurate for the analysis of Tilorone dihydrochloride and its impurities. The wide range of linearity, sensitivity, precision, short retention times and simple mobile phase have shown that the method is suitable for the routine quantification of mass impurities of tilorone hydrochloride and its dosage pharmaceutical forms with high precision and accuracy.

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