“PHARMACEUTICAL QUALITY ASSURANCE THROUGH ANALYTICAL TECHNIQUES: A REVIEW ON NIZATIDINE IDENTIFICATION”

Abstract

Ensuring the quality, safety, and efficacy of pharmaceutical products is essential to public health. This review focuses on the analytical techniques employed in the identification and quality assessment of Nizatidine, a histamine H2-receptor antagonist used in the treatment of gastric ulcers and gastroesophageal reflux disease (GERD). Given its structural similarity to other drugs in its class, such as ranitidine, precise and selective analytical methods are critical for accurate identification and impurity profiling. High-Performance Liquid Chromatography (HPLC) remains the most widely used technique due to its sensitivity and reliability, while advanced methods like Ultra-Performance Liquid Chromatography (UPLC) and Liquid Chromatography–Mass Spectrometry (LC-MS/MS) offer enhanced detection capabilities and reduced analysis time. Stability studies conducted under various stress conditions (heat, light, and moisture) further support shelf-life determination. All methods discussed adhere to international regulatory guidelines (USP, ICH, WHO), ensuring consistency and patient safety. Additionally, the integration of green analytical chemistry principles is emphasized to minimize environmental impact. This review underscores the pivotal role of analytical testing in pharmaceutical quality assurance, with Nizatidine serving as a representative model.