ABSTRACT
A pre-Ultraperformance Liquid Chromatography (UPLC) column derivatization procedure was developed for thesimultaneous quantification of essential amino acids (EAAs) in the solid oral dosage pharmaceutical formulation.This analytical procedure has been validated with the help of the concept of total error. The total error approach (thecombination of systematic and random error) is a decision-making tool for ensuring the performance of the method.Fluorenylmethyloxycarbonyl chloride was used as a derivatization reagent. The amino acid derivatives were separatedon a C18 column (internal diameter 2.1 × 100 mm, 1.6 µm) by gradient elution with 0.1% trifluoroacetic acid andacetonitrile:water (90:10, v/v), respectively, as mobile phase A and B. About 10 EAAs could be detected at 265 nm in35 minutes with a flow rate of 0.25 ml/min. The linearity range of each amino acid was between 0.1 and 1.0 mg/ml.The accuracy and risk profiles were considered acceptable across the range. The precolumn derivatization procedureand the concept of the validation of total error could be used as an appropriate strategy to demonstrate the suitabilityof the analytical procedure for the separation and evaluation of EAA in solid oral dosage formulations.
ABSTRACT
AIM: The aims of this study were to determine. The prevalence of foot complications such as neuropathy, peripheral vascular disease (PVD), amputations and infections and the associated diabetic complications and practice of foot care among these subjects. METHODS: A total of 1319 type 2 diabetic patients, were selected from four different centres across India. The centres were Diabetes Research Centre (DRC), Chennai, Government Rajaji Hospital (GRH), Madurai, Christian Medical College (CMC), Vellore and All India Institute of Medical Science (AIIMS), Delhi. Details were collected regarding foot problems and associated complications. RESULTS: The prevalence of neuropathy was 15% (n=193) and PVD was 5% (n=64). Infections were present in 7.6% (n=100) of patients. The infection rate varied from 6-11% in the different centres. Nearly 3% of subjects had undergone a minor or major amputation. DISCUSSION: This study found that the prevalence of infection was 6-11% and prevalence of amputation was 3% in type 2 diabetic patients. Neuropathy (15%) was found to be an important risk factor for diabetic foot infections. Effective foot care advice should be propagated to reduce the burden imposed by diabetic foot complication particularly in developing countries like India.