Clopidogrel

Clopidogrel is an orally administered medicine that lowers the risk of heart disease. The production process is defined by drug quality, and every pharmaceutical business aims for it, although it is often difficult to attain. The purpose of this study was to look at the quality control parameters of several commercially available Clopidogrel tablets. Four distinct marketed brands of Clopidogrel 75 mg tablets available in the Mangalore market were collected from different pharmacies in Mangalore city to examine the quality. Weight variation, hardness, thickness, and friability, among other quality indicators, were determined according to established protocols. Then there was the in-vitro dissolution test, potency, and disintegration time. All of the brands met the requirements of the Pharmacopoeia since they had a weight fluctuation range that was acceptable. All brands were less than 1% friable, and there were no significant differences in disintegration times, since they all dissolved within 15 minutes. In terms of dissolution profile, all brands had an acceptable dissolving time, releasing more than 60% of the drug in less than 45 minutes. All brands’ hardness fell inside the range. All of the brands also meet the potency requirements. This investigation found that the majority of commercially available Clopidogrel pills in Mangalore are of good quality and meet pharmacopoeia requirements.

The solubility and bioavailability of a drug is very important while preparing a formulation.BCS class-II drugs like clopidogrel have the problem of poor bioavailability because of less solubility. So many novel techniques were available to improve the solubility aspects of drug among which solid lipid nanoparticles is a promising approach. In the current study attempts were made to formulate and evaluate clopidogrel loaded solid lipid nanoparticles by employing cutina as lipid and lecithin soya and PEG-400 and TWEEN-80 were used as surfactant systems. Different formulations were prepared and analyzed for drug content, entrapment efficiency, drug release studies. The selected formulations were analyzed with stability studies at two different conditions which is, room temperature and refrigerated conditions.

The solubility and bioavailability of a drug is very important while preparing a formulation. BCS class-II drugs like clopidogrel have the problem of poor bioavailability because of less solubility.so many novel techniques were available to improve the solubility aspects of drug among which solid lipid nanoparticles is a promising approach.in the current study attempts were made to formulate and evaluate clopidogrel loaded solid lipid nanoparticles by employing cutina as lipid and lecithin soya and PEG-400 and TWEEN-80 were used as surfactant systems. Different formulations were prepared and analyzed for drug content, entrapment efficiency, drug release studies. The selected formulations were analyzed with stability studies at two different conditions which is, room temperature and refrigerated conditions.

A simple, sensitive and rugged quantitative method for the determination of Clopidogrel in human plasma (K2EDTA) using liquid chromatography-tandem mass spectrometric (LC-MS/MS) method has been developed and validated. Clopidogrel-d3 was used as an internal standard. Analyte and the internal standards were extracted from human plasma by liquid-liquid extraction technique using Methyl tertiary butyl ether as extraction solvent and 0.5% formic acid as extraction buffer. The reconstituted samples were chromatographed on a C18 column by using acetonitrile / 5mM ammonium acetate (90/10, V/V) as the mobile phase. The method was validated over the concentration range of 101.98–61028.96 pg/mL. The Quattro Premier XE mass spectrometry was operated under the multiple reaction-monitoring mode (MRM) using the electrospray ionization technique for quantification of ion transitions at m/z 322.13/212.04 and 326.06/215.04 for the drug and the internal standard respectively. The results of the intra and inter batch precision and accuracy studies were well within the acceptable limits. The method has been proved to be simple, sensitive, fast, reliable, rugged and reproducible. A run time of 2.50 min for each sample made it possible to analyze more than 400 plasma samples per day. The proposed method can be applied for the estimation of the drug in real time plasma samples for pharmacokinetic studies. Key words: Clopidogrel, Validation, Human Plasma, LC-MS/MS, Electrospray ionization.