Bioanalysis is an essential part in drug discovery and development. Bioanalysis is related to the analysis of analytes (drugs, metabolites, biomarkers) in biological samples and it involves several steps from sample collection to sample analysis and data reporting. The first step is sample collection from clinical or preclinical studies; then sending the samples to laboratory for analysis. Second step is sample preparation and it is very important step in bioanalysis. In order to reach reliable results, a robust and stable sample preparation method should be applied. The role of sample preparation is to remove interferences from sample matrix and improve analytical system performance. Sample preparation is often labour intensive and time consuming. This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations. Guidance and criteria are given on the application of these validated methods in the routine analysis of study samples from animal and human studies. Measurement of drug concentrations in biological matrices (such as serum, plasma, blood, urine, and saliva) is an important aspect of medicinal product development. It is therefore paramount that the applied bioanalytical methods used are well characterised, fully validated and documented to a satisfactory standard in order to yield reliable results. This review provides an overview of bioanalytical method development and validation and main principles of method validation stages discussed. Keywords: Bioanalysis, Sample Preparation, Bioanalytical Method Development and Validation
To develop a simple, cheap, accurate, and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for estimation of Didanosine in pharmaceutical dosage forms. The separation was conducted by using mobile phase consisting of methanol: water in the ratio (30:70). The wavelength was found at 246nm. Agilent 1220 Infinity LC with ezchrome software is used for chromatographic determination. The separation was conducted by using Zebra Eclipse XDB-C-18 (4.6×250×5µm) at the flow rate of 1.0 ml/min using variable wavelength detector. The developed method resulted in didanosine eluting at 4.650 min. The method was found to be linear over the concentration range 2-12µg/ml with coefficient regression R2-0.997. Mean recovery was found to be in the range of 99.99%, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 5 mg/ml and 16 mg/ml respectively. A cheap, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the quantitative estimation of Didanosine as per ICH guidelines. Keywords:-RP-HPLC, Didanosine, Method Validation
The aim of present research work was to formulate gastro retentive floating tablets containing Ritonavir. The floating tablets of Ritonavir was formulated by direct compression technique using natural, semi-synthetic and synthetic polymers such as gellan gum, HPMC K4M, and carbopol 971p. Sodium bicarbonate was used as gas generating agent. FTIR studies revealed that there is no interaction between the drug and the polymers used in the formulation. Prepared Ritonavir tablets were evaluated by various quality parameters including weight variation, hardness, friability, drug content, tablet density, floating test, swelling index, in-vitro drug release and showed satisfactory results. Formulations F2, F5, F6 showed satisfactory drug release of 90.3%, 94.3%, and 97.7% respectively. The optimized batch F6 shows good results and extended drug release.
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