RESUMO
Background: Chronic abdominal pain (CAP) is a prevalent condition with a wide etiology and is often associated with significant health care utilization. A functional diagnosis, particularly, Functional abdominal pain syndrome (FAPS) is more challenging and has been a less extensively studied condition in adults as compared to other common functional gastrointestinal disorders. Hence, this study attempts to formulate a definite line of investigations, study various causes of chronic abdominal pain and to evaluate FAPS, in a population from Central India. Methods: 100 patients in the age-group of 10-60 years with chronic abdominal pain were selected. A careful history, clinical examination and investigations were performed and final diagnosis was made on the basis of the available data. Results: Eighty-nine out of hundred patients were found to be having some organic disorder causing CAP while eleven had functional gastrointestinal disorders. FAPS was diagnosed in three patients on the basis of Rome III diagnostic criteria while one had unspecified functional abdominal pain. Conclusions: CAP is a multifactorial condition yet, a thorough history coupled with a complete physical examination and investigative profile help to a great extent in diagnosing the cause. FAPS should be diagnosed on the basis of a careful clinical history and characteristic pain behaviour during physical examination. A cost-effective and conservative approach should be adopted for investigations. Unlike the organic causes, FAPS should be treated with a biopsychosocial approach with a variable combination of pharmacological, cognitive-behavioural and psychological interventions.
RESUMO
Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results. Additionally, there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug product. In the present work, evaluation of risk profile, combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were studied. Uncertainty was calculated using cause-effect approach, and to make it more accurately applicable a method was validated in our laboratory as per the ICH guidelines. While assessing the results of validation, the calibration model was justified by the lack of fit and Levene’s test. Risk profile represents the future applications of this method. In uncertainty the major contribution is due to sample concentration and mass. This work demonstrates the application of theoretical concepts of calibration model tests, relative bias, risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.
RESUMO
A Simple and precise HPLC method was developed for the simultaneous estimation of Ramipril and Amlodipine in pure drug and pharmaceutical dosage forms. The separation was carried out using C18 Column (250 × 4.6 mm i.d. 5 μm particle size), with mobile phase compressing of Acetonitrile, Sodium phosphate buffer and Methanol in the ratio of 50: 20:25 v/v/v, pH= 6.8 (pH adjusted with OPA). The flow rate was 0.8 ml/min and the detection was carried out using PDA detector at 210 nm. The retention times were 2.64 and 7.45 mins for Ramipril and Amlodipine respectively. Calibration curves were linear with correlation coefficient 0.998 and 0.996 over concentration range of 1 - 16 μg/ml for Ramipril and 0.2 – 3.2 μg/ml for Amlodipine respectively. Recovery was found in between 100.21% and 100.82% for Ramipril and Amlodipine respectively. Method was found to be reproducible with relative standard deviation (R.S.D) for intra and inter day precision less than 2%. The method was validated by evaluation of different parameters such as accuracy, linearity, precision, LOD and LOQ.