Validated High Performance Liquid Chromatography Method for Analysis of Cefadroxil Monohydrate in Human Plasma

Purpose: To develop a simple, rapid and sensitive high performance liquid chromatography (HPLC) method for the determination of cefadroxil monohydrate in human plasma.Methods: Schimadzu HPLC with LC solution software was used with Waters Spherisorb, C18 (5 μm, 150mm × 4.5mm) column. The mobile phase was sodium dihydrogen phosphate buffer pH 4.0 and methanol in a ratio of 96:4. Flow rate was 1.5 ml/min and injection volume was 100 μl. Peak response was detected at 260 nm.Results: System suitability results revealed that the coefficient of variation (CV) for retention time, peak response, tailing factor and resolution of six replicate injections was < 3 %. The method was selective to determine cefadroxil in plasma because there was no peak interference of plasma with cefadroxil at its retention time (7.792 min). Linearity was in the range of 0.5 - 30 μg/ml with slope and intercept of 41694.53 and 22614.87, respectively (R2 = 0.9953). Limit of detection (LOD) and lower limit of quantification (LLOQ) of the method were 0.03 and 0.06 μg/ml, respectively. Absolute recovery of cefadroxil from plasma was in the range 71 - 90.4 %, while inter-day and intra-day analysis showed satisfactory precision and accuracy; thus, the method was reproducible with the range of CV, i.e., 0.35 - 4.01 and 1.88 - 7.9 % for interday and intraday precision, respectively.Conclusion: The developed method being simple, rapid, reproducible can be suitably employed in pharmacokinetic and bioequivalence studies of cefadroxil monohydrate.Keywords: Validation, Cefadroxil monohydrate, Human plasma, Pharmacokinetics Bioequivalenc

Global variation in anastomosis and end colostomy formation following left-sided colorectal resection

Background End colostomy rates following colorectal resection vary across institutions in high-income settings, being influenced by patient, disease, surgeon and system factors. This study aimed to assess global variation in end colostomy rates after left-sided colorectal resection. Methods This study comprised an analysis of GlobalSurg-1 and -2 international, prospective, observational cohort studies (2014, 2016), including consecutive adult patients undergoing elective or emergency left-sided colorectal resection within discrete 2-week windows. Countries were grouped into high-, middle- and low-income tertiles according to the United Nations Human Development Index (HDI). Factors associated with colostomy formation versus primary anastomosis were explored using a multilevel, multivariable logistic regression model. Results In total, 1635 patients from 242 hospitals in 57 countries undergoing left-sided colorectal resection were included: 113 (6·9 per cent) from low-HDI, 254 (15·5 per cent) from middle-HDI and 1268 (77·6 per cent) from high-HDI countries. There was a higher proportion of patients with perforated disease (57·5, 40·9 and 35·4 per cent; P < 0·001) and subsequent use of end colostomy (52·2, 24·8 and 18·9 per cent; P < 0·001) in low- compared with middle- and high-HDI settings. The association with colostomy use in low-HDI settings persisted (odds ratio (OR) 3·20, 95 per cent c.i. 1·35 to 7·57; P = 0·008) after risk adjustment for malignant disease (OR 2·34, 1·65 to 3·32; P < 0·001), emergency surgery (OR 4·08, 2·73 to 6·10; P < 0·001), time to operation at least 48 h (OR 1·99, 1·28 to 3·09; P = 0·002) and disease perforation (OR 4·00, 2·81 to 5·69; P < 0·001). Conclusion Global differences existed in the proportion of patients receiving end stomas after left-sided colorectal resection based on income, which went beyond case mix alone