RESUMEN
Objective: To develop a simple, rapid, precise and reproducible liquid chromatographic method for the estimation meropenem (MEP) and vaborbactam (VAB) in bulk and pharmaceutical formulation and study of the stability of the drugs in different stressed conditions. Methods: The chromatographic separation was achieved on a Kromasil C18 column (250 × 4.6 mm) using a mobile phase composition of acetonitrile and 10 mmol phosphate buffer (pH 3.50) in a ratio 30:70 v/v, pumped at a flow rate of 1.0 ml/min with UV detection set at 260 nm. Results: Symmetrical and sharp peaks of MEP and VAB were obtained at retention times of 2.29 and 3.10 min, respectively. The chromatographic method was validated for linearity, limits of detection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in the concentration ranges of 25–150 μg/ml for MEP and VAB. Stability tests done through the exposure of the analytes solution for different stress conditions and the obtained results indicate no interference of degradants with HPLC method. Conclusion: The proposed method has been found to be selective, precise, linear, accurate, and sensitive. The method can be successfully applied to the assay determination of bulk drugs and combined dosage forms for routine analysis.
RESUMEN
Co-existence of obesity and type 2 DM exacerbates metabolic and other remediable health consequences further. Various pharmacological therapies have been adopted when changing of lifestyle fail to achieve target glycaemic control. Our objective is to find out whether Orlistat can reduce both weight and need for oral hypoglycaemic agent (OHA) and improves glycaemic status,lipid disorders, blood pressure in Bangladesh type 2 DM with obesity. In this center, open-label, randomized, controlled pilot trial 36 type 2 patients with obesity were enrolled. All patients aged 40-65 years had BMI >25 kg/m2 taking sulfonylureas and hypocalorie diet. Twenty one randomly cases were treated with orlistat 120 mg three times daily for 6 months and 15 without orlistat as control. Body weight, waist circumferances, fasting blood sugar, HbAlc,serum lipids, blood pressure and dose of drugs were monitored at 0,12, 24 weeks. After 6 months, orlistat group showed non-significant weight loss than control group (3.95% vs 1.42% from base lines), but showed significant reduction of waist circumference (6 % vs 0.63 %, p<0.01 vs p>0.05 from base line). Orlistat group had significant improvement in glycaemic status (HbA1c changes: 22.37% vs 13.38%, p<0.001 vs p>0.05 and FBS changes: 21.76% vs 22.95%, p<0.01vs p<0.05). Lipid profile had reduced significantly from base lines (Chol: 19.31% vs 9.12%,p<0.001vs >0.05; LDL Chol: 24.99% vs 19.09%, p<0.001 vs p<0.01; Triglyceride: 34.48% vs 12.61%, p<0.001 vs p>0.05). Diastolic pressure had improved significantly in orlistat group (6.73% vs 3.70%, p<0.01 vs >0.05). Reduction of OHA doses were found in both groups. Thus orlistat can be used as an adjuvant therapy with other OHA in managing glycaemic control, lipid profiles and blood pressure.