HPLC Method Development Troubleshooting: Common Problems, Root Causes and Practical Solutions HPLC method development is an important part of pharmaceutical analytical development because the quality of the analytical method directly affects the reliability of assay, related substances, dissolution, and other testing results. During method development, analysts commonly face problems such as poor peak shape, low … Read more

HPLC Assay Calculation Formula Introduction: For pharmaceutical drug products such as tablets, capsules, injections, solutions, and suspensions, HPLC assay is generally calculated by comparing the sample peak response (area) with the standard peak response, while considering standard potency, sample weight, dilution factors, average tablet/capsule weight, and label claim. 1. Basic HPLC Assay Formula A commonly … Read more

Pharmaceutical Stability Studies Introduction: Pharmaceutical stability is a critical part of drug development and quality control that determines how the quality, safety, strength, purity, and efficacy of a drug product change with time under different environmental conditions. A stability study provides scientific evidence for establishing the shelf life, retest period, storage conditions, packaging requirements, and … Read more

Analytical Method Validation Introduction: HPLC method validation is one of the most important activities in pharmaceutical analytical method development because it demonstrates that an analytical method is suitable for its intended purpose. A method may provide a good peak shape, acceptable retention time, and satisfactory resolution during method development, but these observations alone are not … Read more

BCS Classification in Dissolution Method Development Introduction: BCS classification (Biopharmaceutics Classification System) is an important concept in pharmaceutical development because it connects the solubility and permeability of a drug substance with its expected absorption and dissolution behaviour. A highly soluble drug may dissolve rapidly, while a poorly soluble drug may require more carefully designed dissolution … Read more