International Journal of Pharmaceutical and Biological Science Archive

Regulatory Compliance in the Pharmaceutical Industry

Thu, 13 Feb 2025 06:58:26 +0000

Regulatory compliance in the pharmaceutical industry is crucial to ensuring public safety, product quality, and business sustainability. Companies must adhere to stringent guidelines, stay informed of evolving regulations, and invest in robust systems and employee training. Challenges include navigating complex international rules, keeping pace with technological advancements, and managing data integrity. Best practices, such as implementing Quality Management Systems (QMS), conducting regular audits, leveraging digital learning platforms, and embracing automation, are essential to maintaining compliance and building trust within the industry. In 2025 and beyond, these strategies are vital for mitigating risks and upholding high standards in pharmaceutical manufacturing.

A Review on the Herbal Treatment for Hypercholesterolemia Using Plants from the Zingiberaceae Family Plants

Thu, 13 Feb 2025 00:00:00 +0000

Hypercholesterolemia, a major risk factor for cardiovascular diseases, has become a significant global health concern. Conventional lipid-lowering agents, though effective, often carry side effects that drive the search for safer alternatives. In recent years, medicinal plants from the Zingiberaceae family have gained attention for their potential role in managing cholesterol levels due to their rich phytochemical content, including flavonoids, terpenoids, and phenolic compounds. This review aims to explore the therapeutic efficacy of Zingiberaceae family plants, particularly focusing on Zingiber officinale (ginger), Curcuma longa (turmeric), and Alpinia galanga (greater galangal), in the management of hypercholesterolemia. The bioactive compounds within these plants have shown promising effects on lipid metabolism, including the reduction of total cholesterol, low-density lipoprotein (LDL), and triglycerides, while elevating high-density lipoprotein (HDL). This review will also discuss the molecular mechanisms underlying the cholesterol-lowering effects of Zingiberaceae species, providing insight into their potential as complementary therapies in hypercholesterolemia management.

Keywords: Hypercholesterolemia, Herbal treatment, Lipid metabolism, Zingiber officinale, Curcuma longa, Alpinia galangal

Bioanalytical Method Development and Validation for Letrozole Tablet by LC MS

Foram Pradeepkumar Patel, Zarna Dedania — Thu, 13 Feb 2025 00:00:00 +0000

The main objective of this work is to develop rapid, selective and sensitive LC-MS/MS method that have short and simple extraction procedures, consume small amounts of solvent and biological fluid for extraction and a short turn-around time. Need for the development of method and validation by HPLC Method for letrozole for better accuracy, precision and higher sensitivity and recovery rate from human plasma sample. The drug candidate letrozole API purchased from Biodeal Pharmaceutical (Himachal Pradesh). HPLC Model Shimadzu 2030, Column: 4.6mm×25cm Fine-pack C₈ Steel Column, Software: Cromalion 7.2, Analytical balance: Shimadzu, pH meter: Toshcon Industries and LC-MS: Sciex QTRAP 4500 used for the entire research work. Optimization of chromatography in HPLC Method for letrozole using Mobile Phase as Water: Acetonitrile: Methanol (50:30:20 v/v/v) any many trials has been taken for variation in mobile phase, flow rate 1 mL/min and other parameters till the optimized chromatogram was observed, Extraction Technique LLE completed and observed mean value 4502.00, SD value 7.19 and % RSD were found 0.16 for method precision. The Mean value 4499, and SD 3.49 and %RSD 0.08 for System Suitability found. Recovery at LOQ level 2.35 SD, 0.26%RSD, Recovery at 100% level 3.33 SD, 0.07%RSD and Recovery at 150% level 3.31 SD, 0.05%RSD was observed. For method development of tablet formulation 2.5 mg the mean value observed 4489, 9.19 SD and % RSD 0.20 observed. The Regression Statistics data LLOQ and LOD for regression analysis were found 1.369 ng/ml and 0.637 ng/ml respectively, so the sensitivity of developed methods was very high rather than other available methods.

Keywords: Letrozole, Bio-analytical Method Development, LLOQ, Method Validation

Bioanalytical Method Development and Validation for Letrozole Tablet by LC-MS

Foram Pradeepkumar Patel, Zarna Dedania — Thu, 13 Feb 2025 00:00:00 +0000

Keywords: Letrozole, Bio-analytical Method Development, LLOQ, Method Validation