Vinod kumar

The majority of pharmaceuticals used today are chiral. A brief summary of various chiral separation principles and associated separation methods is provided in this review. Liquid chromatography (LC), capillary electrophoresis (CE), high-performance liquid chromatography (HPLC), and gas chromatography (GC) are only a few of the recent advancements addressed. The creation of competent analytical techniques is essential for compliance with the numerous regulatory obligations. The rapid development of chiral separation technologies has been fueled by the current situation in which chirality factors are taken into account in therapeutic benefit and drug development. High-performance liquid chromatography (HPLC) and gas chromatography (GC) have unquestionably made important advancements in chiral chromatographic technology, opening the door to the quantification of specific enantiomers of a number of racemates in biological fluids such plasma, serum, urine, etc. Chiral compound separations and analyses are crucial in a variety of industries, such as biology, pharmaceutical manufacturing, and the creation of chemical intermediates.

The quantitative analysis of bulk materials, drug formulations, drug products, impurities, and biological products containing pharmaceuticals and their metabolites is challenging in the field of pharmaceutical research. It is also complicated to choose the best method. Pharmacokinetic studies frequently make use of quantitative or qualitative studies of a drug and its metabolite. Developing a generic product with quantitative equivalence, which increases regulatory flexibility, seems to be the ultimate aim. Knowing the exact components of reference items and their concentrations is extremely helpful when developing generic formulations. The quantitative composition of the dosage forms is kept secret by the innovators. In such a situation, the quantitative formula of the dosage form is being decoded by generic manufacturers through reverse engineering. To quantify them, we need reliable, non-destructive analytical tools. In this article, we covered excipient quantification techniques, analytical data reports, challenges, and applications.

The purpose of the present study was to enhance the solubility and dissolution rate of a poorly water soluble drug by solid dispersion technique. Irbesartan was used as a model drug to evaluate its release characteristics from the formulations. Solid dispersions of Irbesartan with PEG 4000 and PEG 6000 were prepared by physical mixing, solvent evaporation and melting techniques in w/w ratios (drug: carrier). Characterization of the solid dispersions was carried out by Differential Scanning Calorimetry (DSC) and Fourier Transform Infra-Red spectroscopy (FTIR). The dissolution profiles of solid dispersions were compared with those of the pure drug. Solid dispersions of Irbesartan with PEG 4000 prepared by solvent evaporation technique at 1:1 ratio showed greater dissolution compared to other formulations. FTIR and DSC studies showed no significant interaction between Irbesartan and the hydrophilic carriers.

A simple, accurate, precise, specific, sensitive, reproducible and Reliable RP- HPLC Method was developed for Quantitative Estimation of Metaxalone and Diclofenac potassium in Pharmaceutical Dosage Form. The developed RP- HPLC method with the mobile phase Methanol: Water (80: 20) and Qualisilgold-C18 (250Χ4.6mm, 5μm particle size) as stationary phase with a flow rate of 1.0 mL/minute by using λmax 275nm and PDA detector. Proposed method was found to be linear in the concentration range of 8.0 to 80.0 μg/mL for Metaxalone and 1.0 to 10.0 μg/mL for Diclofenac potassium respectively, and the correlation coefficient was found to be 0.9991 for both the drugs. Precision study showed that the % RSD was within the range of acceptable limits (< 2), and the % Recovery was found to be in the range of 99.29%-101.28% for Metaxalone and 99.98%-102.45% for Diclofenac potassium. The proposed method has been validated as per ICH guidelines.