![]() ![]() The present method was successfully applied to the determination of the OA content and partition coefficient of OA in SE-OA during the early stage of formulation development. Steps for Method Validation: Validation Protocol: Validation protocol is a document that indicates the company’s approach to validation of analytical procedures. The validation results confirmed that the method is specific, linear, accurate, precise, robust and sensitive for its intended use. As per FDA method validation is defined as the process of proving (through scientific studies) that an analytical method is acceptable for its intended use. The percent relative standard deviations (% R.S.D.) of intra-day and inter-day analyses were less than 3.1%. Analytical method validation is the process used to authenticate that the analytical procedure employed for a specific test is suitable for its intended use. Following is a step-by-step guide for preparing protocols and performing test methods validation with reference to HPLC. ABB provides training and technical support guiding you to the ideal PLC Automation. The individual spike recovery of OA ranged from 99.88 to 100.28%. Develop a Validation Protocol The first step in method validation is to prepare a written and approved protocol with the instructions in a clear step-by-step format. The LOD and LOQ were 0.1 and 1 microg/mL, respectively. The calibration curve was linear over a concentration range of 2-100 microg/mL with a correlation coefficient of 0.999. ![]() This two-part webinar series covers setup, sample sizes, metrics for success, and diagnosing and. With the successful implementation of TMV, you can minimize the risks of rejecting a good product or shipping a defective product. The analyses were performed at 35 +/- 1 degrees C with a flow rate of 1.0 mL/min and variable wavelength detector (VWD) at 210 nm. Test Method Validation (TMV) is not only an FDA regulatory requirement, it is key to quality and financial success. The OPLC method was preferred for process-validation because it shows a short analysis time and low eluent. A Diamonsil C18 (150 mm x 4.6 mm, 5 microm) column was eluted with a mobile phase consisting of methanol/water (95:5, v/v). Both OPLC and HPLC are suitable for purity testing. The aim of this study was to develop and validate a simple HPLC method for the quantitative determination of the oleanolic acid (OA) content and partition coefficient of OA in a submicron emulsion-based formulation (SE-OA). ![]()
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