Stability Indicating Method Development and Validation for the Estimation of Bempedoic Acid by RP-HPLC.

BACKGROUND: Bempedoic acid (BEM) belongs to a category of drugs known as Adenosine triphosphate-citrate Lyase (ACL) inhibitors. It is a prodrug with intracellular activation that is administered orally. Bempedoic acid is used to treat existing atherosclerotic cardiovascular diseases, mainly hypercholesterolemia. METHODS: For the stability-indicating assay, the HPLC method was employed using a Kromasil 100-5-C8 column (100 mm × 4.6 mm), a UV detector set at 230 nm, and a mobile phase comprising a 70:30 v/v mixture of acetonitrile and 0.1% Orthophosphoric Acid (OPA) buffer. The method was operated at an ambient temperature with a flow rate of 1 mL/min. The method developed has been statistically validated according to ICH guidelines. RESULTS: The stability-indicating method was executed using a Kromasil 100-5-C8 (100 mm × 4.6 mm) column at a 1.0 mL/min flow rate. A mixture of acetonitrile and 0.1% Orthophosphoric Acid (OPA) buffer in a 70:30 v/v ratio made up the mobile phase. BEM's retention times were discovered to be 1.88 minutes each. The temperature was kept at room temperature. 234 nm was the ideal wavelength for BEM. According to ICH criteria, the approach developed has undergone statistical validation. BEM's % RSD was discovered to be 0.6, respectively. For BEM, the % recovery was determined to be 100.0%. Regression models for bempedoic acid yielded LoD and LoQ values of 3.3 and 10.1 g/mL, respectively. The method showed good reproducibility and recovery with a % RSD less than 2. Studies on forced degradation confirmed the method's capacity to indicate stability in the presence of stress conditions, such as acid, basic, peroxide, UV, heat, and humidity. Both the retention times and the run time were shortened. CONCLUSION: In accordance with ICH Q2 (R1) guidelines, this method was successfully tested with HPLC to confirm the chemical structures of newly produced degradation products of bempedoic acid.

Recent Advances in Microwave Assisted Extraction of Bioactive Compounds from Complex Herbal Samples: A Review.

Microwaves are utilized for extraction of Phytoconstituents from complex herbal sample as a result of incredible research. Conventional extraction strategies are tedious and need more solvents and are no more relevant for thermal sensitive plant components. This review emphasize on the working and significance of microwave extraction technology in herbal research and medical field. The extraction step must be more yielding; quick, particular, not more solvent consuming, ensuring stability of thermolabile components and these features are available with microwave extraction method. In this nonconventional technology heat is created utilizing microwave energy. The important parameters that influence extraction efficiency are solvent properties, volume, duration of exposure, microwave control, system attributes, temperature and application were discussed in this article. The microwave assisted extraction, as green technology is contrasted with other extraction technique. This review is intended to discuss this green extraction technique along with its critical parameters for extracting bioactive compounds from complex plant matrices.

Simultaneous determination of metronidazole and miconazole nitrate in gel by HPTLC.

A new, simple, precise, rapid and selective high-performance thin-layer chromatographic (HPTLC) method for the simultaneous quantification of Metronidazole (MTZ) and Miconazole nitrate (MCZ) in gel has been developed. It was performed on silica gel 60 GF254 Thin Layer Chromatographic plates using mobile phase comprising of Toluene: Chloroform: Methanol (3.0:2.0:0.6 v/v) and the detection was carried out at 240 nm using densitometer. The retention factors of MTZ and MCZ were 0.34 and 0.55 respectively. Calibration curves were linear in the range of 300-700 ng/spot of MTZ and 600-1400 ng/spot of MCZ both by height and by area. The percent recovery of the drugs from gel carried out by standard addition method was found to be 100.13+/-1.59 (by height) and 98.92+/-0.76 (by area) for MTZ and 99.49+/-1.58 (by height) and 99.63+/-1.46 (by area) for MCZ indicative of accuracy and precision of simultaneous determination of MTZ and MCZ nitrate.