In Vitro Dissolution and Kinetic Assessment of Reference and Generic Levocetirizine Hydrochloride Tablets Under Biorelevant Conditions

Dissolution testing is a critical quality control tool used to evaluate the in vitro drug releasebehavior of oral solid dosage forms and to predict there in vivo performance. The present studyaimed to assess and compare the dissolution profiles of a reference and two genericformulations of Levocetirizine Hydrochloride 5 mg tablets under biorelevant conditionssimulating the gastrointestinal environment. Levocetirizine Hydrochloride, a widely prescribedantihistamine for the management of allergic rhinitis and urticaria, requires consistent releasecharacteristics to ensure therapeutic efficacy. Dissolution studies were conducted using a USPdissolution apparatus under controlled laboratory conditions in three media representingphysiological pH environments: 0.1 N hydrochloric acid (pH 1.2), acetate buffer (pH 4.5), andphosphate buffer (pH 6.8). Samples were collected at predetermined time intervals (5, 10, 15,30, 45, and 60 minutes), and drug release was quantified using validated analytical methods.The results demonstrated a progressive and consistent increase in drug release across allformulations and media. Rapid dissolution was observed in acidic conditions, indicatingefficient drug release in gastric pH, while sustained and comparable release profiles weremaintained in acetate and phosphate buffers, reflecting intestinal conditions. Comparativeanalysis revealed that both generic formulations exhibited dissolution behavior similar to thereference product across all media. Method validation parameters confirmed the reliability ofthe analytical approach, with precision (%RSD < 2%), accuracy (recovery within 99–101%),and robustness demonstrating minimal variability under slight experimental changes.Furthermore, similarity factor (f₂ > 50) and difference factor (f₁ < 15) values confirmedequivalence between generic and reference formulations. In conclusion, the studiedformulations exhibited comparable and consistent dissolution profiles under physiologicallyrelevant conditions, supporting their pharmaceutical equivalence and potentialinterchangeability. This study highlights the importance of dissolution testing as a predictiveand regulatory tool for ensuring the quality, performance, and therapeutic reliability of oralsolid dosage forms.