Bioanalytical Method Development and Validation: A Review

For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, the data related to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch (HPB), Association of analytical chemists (AOAC), Center for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration(CFDA), European Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done collective efforts at different timings to regulate and harmonize bioanalytical method development and validation

SYNTHESIS, CHARACTERIZATION AND QUANTITATION OF REGIOISOMERIC IMPURITY IN NIMODIPINE BULK AND FORMULATION

Objective: The present research work was directed towards the synthesis characterization and quantitation of regioisomeric impurity of Nimodipine i.e. diethyl 1, 4-dihydro-2,6-dimethyl pyridine dicarboxylate in bulk and tablet formulation, by UV,IR,NMR and GC-MS techniques and a RP-HPLC method was developed as per ICH Q2B guidelines for quantitation of 1, 4-Dihydro-2, 6-Dimethyl-4-(p-nitro phenyl) pyridine-3,5 dicarboxylate (NI) from bulk and formulation. Methods: The synthesis of NI was carried out by Hantzch pyridine synthesis, by using p-nitrobenzaldehyde, ethylacetoacetate, in presence of ammonia and methanol as a catalyst. The percentage yield was found to be 89.29%. Recrystallization and purification of NI was done. The preliminary evaluation was done on laboratory scale via melting point, elemental analysis and TLC. Results: The melting point of impurity was found to be 156-1580C. The TLC of impurity was carried by using Chloroform: Methanol (9:1) and the Rf was found to be 0.79. The confirmation of structure of NI was carried out by using sophisticated techniques i.e., FT-IR, NMR (13C and 1H), GC-MS etc. The RP-HPLC method was developed to quantify the NI in Nimodipine bulk and formulation as per ICH Q2B guidelines. The method validation was done as per ICH guidelines. Conclusion: The validated optimized method was found to be linear, précised, robust, rugged and accurate. Finally NI was quantified from bulk Nimodipine and its marketed tablet formulation. It was concluded that the amount of NI, present in tablet was found to be 0.1% and in the bulk 0.067% respectively. Thus it was revealed that the NI was found to be within the limit laid down ICH guidelines (Not more than 0.1 %)

Anticonvulsant and behavioral actions of triterpene isolated from <i>Rubia cordifolia </i>Linn.

675-680Effect of a triterpene isolated from the acetone soluble part of petroleum ether extract of R. cordifolia was studied on convulsions induced by maximum electro shock (MES), electrical kindling and various chemoconvulsants in rats and mice. The effect of triterpene was also investigated on behavior and gamma-aminobutyric acid (GABA) and serotonin (5-HT) content in mouse brain. Triterpene inhibited seizures induced by MES, electrical kindling, pentylenetetrazol (PTZ), and lithium-pilocarpine. However, seizures induced by strychnine were not inhibited. Triterpene reduced locomotion as well as rearing. Pentobarbitone induced sleep was potentiated and amphetamine induced stereotypy was inhibited. The triterpene was found to possess anxiogenic activity. Brain GABA and 5-HT contents were raised by the compound. The study suggests that the triterpene isolated from R.cordifolia bear a potential for further study

Dye plants: Natural resources from traditional botanical knowledge of Sardinia Island, Italy

651-656<span style="mso-bidi-font-size: 11.0pt;mso-fareast-font-family:Calibri" lang="EN-GB">Now a days the use of wild plant species for colouring textile articles is very modest in Europe, mainly because of the incessant production of synthetic dyes, which are economic and easy to find. The tradition of using dye plants still persists in the Mediterranean region, but is not widely studied. In this paper, the authors, for the first time, study the natural colours and wild species used in the popular Sardinian tradition. They try to bring order and Scientific rigor of an important topic, with an emphasis on the economic value of knowledge passed down orally from generation to generation. </span

Medical ethnobotany survey of the Senegalese community living in Cagliari (Sardinia, Italy)

275-282The present work aims to study the use of plant species with curative intent within the Senegalese community who live in the city of Cagliari (Sardinia, Italy). The article mainly focuses on the integration of traditional medicine and biomedicine, on the codification of knowledge capital, behaviors, as well as health information. The purpose of this investigation is to: shed light on this interesting and somewhat unknown wealth of knowledge, enhance it and evaluate the process of integration with the local culture. We have tried to define, through an ethnobotanical survey, the plant species used traditionally to treat various ailments and gather the knowledge that different members of the community have of them. The survey revealed the use of 23 plant species belonging to 11 families, with a prevalence of Fabaceae (30.4%), Anacardiaceae, <i style="mso-bidi-font-style: normal">Combretaceae and Malvaceae (13% each). An overall analysis of data showed that, in addition to the therapeutic uses to treat diseases of easy resolution, there are also applications for specific diseases, such as leprosy, diabetes and malaria. </span