eng Oriental Scientific Publishing Company Biosciences Biotechnology Research Asia 0973-1245 2026-10-08 23 3 59892 article Kiran Dhamak 1 Rahul Dnyaneshwar Khaire 1 Sheetal Gosavi 2 Kiran Kotade 3 Dheeraj Chechare 4 Department of Pharmaceutical Chemistry, PRES’s College of Pharmacy (For Women), Nashik, India Department of Pharmaceutics, PRES’s College of Pharmacy (For Women), Nashik, India Department of Pharmacology, PRES’s College of Pharmacy (For Women), Nashik, India Department of Pharmaceutics, PRES’s College of Pharmacy (D.Pharm), Nashik, India Process-related impurities in active pharmaceutical ingredients (APIs) are critical quality attributes that must be identified and quantified to ensure the safety, efficacy, and regulatory compliance of pharmaceutical products. The present study aimed to synthesize a process-related impurity of Lacidipine and develop and validate a simple, sensitive, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method for its estimation in bulk drug and pharmaceutical formulations. The impurity, 3-(2-[3,5-bis(ethoxycarbonyl)-1,4-dihydropyridin-4-yl]phenyl)prop-2-enoic acid, was synthesized using the Hantzsch pyridine reaction and characterized prior to chromatographic analysis. Separation was achieved on a C18 column using an optimized methanol (60:40, v/v) mobile phase under isocratic conditions. The method was validated according to ICH Q2(R2) guidelines for specificity, linearity, precision, accuracy, sensitivity, and system suitability. The developed method exhibited excellent linearity over the concentration range of 1–6 µg/mL (R² = 0.999), with precision (%RSD <2%), satisfactory recovery (98–103%), and acceptable system suitability parameters, demonstrating reliable chromatographic performance. The validated method was successfully applied for the quantification of the process-related impurity in Lacidipine bulk drug and commercial tablet formulations, confirming its suitability for routine quality control and impurity profiling. The proposed RP-HPLC method provides a reliable, robust, and practical analytical approach for the determination of Lacidipine process-related impurities and supports regulatory requirements for pharmaceutical quality assurance. https://www.biotech-asia.org/vol23no3/development-and-validation-of-an-rp-hplc-method-for-estimation-of-process-related-impurities-of-lacidipine-in-bulk-drug-and-pharmaceutical-formulations/ HPLC; Impurity; Lacidipine; Method validation; ProcessValidation