ABSTRACT
A simple, accurate, precise and robust stability indicating RP-HPLC assay method has been developed for the estimation of trimethobenzamide in stress sample. An isocratic separation of trimethobenzamide was achieved on Kromasil 100 C-18 column (250 X 4.6mm, 5µ) with a flow rate of 1.0 ml/min and by using a photodiode array detector to detect the analyte at 213nm. The optimized mobile phase consisted of methanol: ammonium formate (44:56, v/v). The drug was subjected to different forced degradation conditions according to ICH guidelines including acid, base, neutral hydrolysis, oxidation, photolysis and thermal degradation. Degradation products were found only in basic and oxidative degradation conditions. All the degradation products got eluted in an overall analytical run time of 12min. The developed analytical method has been validated according to the ICH guidelines. Response of trimethobenzamide was linear over the concentration range of 0.5-50µg/mL (r2 = 0.999). Accuracy was found to be in between 94.03% to 100.39%. Degradation products resulting from the stress studies did not interfere with the detection of the analyte.
Subject(s)
Chromatography, High Pressure Liquid/methods , /analysis , Validation Study , Methods , Pharmaceutical Preparations/administration & dosage , HydrolysisABSTRACT
Management of cardiovascular risk factors in diabetes demands special attention due to their co-existence. Pioglitazone (PIO) and telmisartan (TLM) combination can be beneficial in effective control of cardiovascular complication in diabetes.In this research,we developed and validated a high throughput LC–MS/MS method for simultaneous quantitation of PIO and TLM in rat plasma. This developed method is more sensitive and can quantitate the analytes in relatively shorter period of time compared to the previously reported methods for their individual quantification. Moreover, till date, there is no bioanalytical method available to simultaneously quantitate PIO and TLM in a single run. The method was validated according to the USFDA guidelines for bioanalytical method validation.A linear response of the analytes was observed over the range of 0.005–10μg/mL with satisfactory precision and accuracy. Accuracy at four quality control levels was within 94.27%–106.10%. The intra-and inter-day precision ranged from 2.32% to 10.14% and 5.02% to 8.12%,respectively.The method was reproducible and sensitive enough to quantitate PIO and TLM in rat plasma samples of a preclinical pharmacokinetic study.Due to the potential of PIO-TLM combination to be therapeutically explored,this method is expected to have significant usefulness in future.
ABSTRACT
The present study was aimed to explore the acute and sub chronic toxicity studies with orally administered ethanolic leave extract of Epipremnum aureum. For the acute toxicity study, the animals were divided into four groups and each group receives a dose of (50, 500, 2000) mg/kg except control group which receives only 1% CMC. They were observed for 14days for signs of toxicity. In case of sub chronic toxicity, the Sprague dawley rats were fed with ethanol extract (100, 600, and 1000) mg/kg per day for 28 days. The parameters measured include organ weight, biochemical test, haematological test and histopathological observations. Acute oral administration of Epipremnum aureum did not show any mortality, CNS and ANS toxicities. Similarly in subchronic toxicity studies, Epipremnum aureum did not show any visible signs of toxicity. There were also no significant differences between the control and extract treated groups in terms of their organ weight, haematological and biochemical parameters. Histopathological examination did not reveal any remarkable and treatment related changes. A no-observed adverse-effect level for extract is 2000 mg/kg for rats under the conditions of this study. Hence, the extracts could be considered safe at the doses administered since they did not provoke toxic effect on the key organs examined and also did not alter any biochemical and haematological parameters.