TY - JOUR ID - 88423 TI - Simultaneous Determination of Amlodipine Besylate, Valsartan, and Its Related Substances in Their Film-Coated Tablets Dosage form by RP-HPLC Method JO - Advanced Journal of Chemistry, Section A JA - AJCA LA - en SN - 2645-7768 AU - Mohamed, Mahmoud Abdelfatah AD - HIKMA group, Pharmaceutical Company, Beni-Suef, Egypt Y1 - 2019 PY - 2019 VL - 2 IS - 4 SP - 335 EP - 346 KW - Amlodipine Besylate KW - valsartan KW - related substances RP-HPLC KW - Dissolution KW - stability indicating method KW - Tablet dosage form DO - 10.33945/SAMI/AJCA.2019.4.7 N2 - The current study aimed to develop and new, simple, accurate, economical and stability-indicating RP-HPLC for simultaneous estimation of Amlodipine Besylate, Valsartan and its related substances in their film-coated tablets dosage form. Chromatographic system was performed on the YMC ODS-A C18 (150 mm × 4.6 mm, 5μm particle size) using a binary gradient elution consist of two solvent systems, solution (A) 0.02 monobasic sodium phosphate Adjust with phosphoric acid to a pH of 2.5. and solution (B) consisting of Solution A: Acetonitrile (45:55). at a flow rate of 1.0 mL/min, injection volume 10 µL, UV detection at 235 nm, column oven temperature 30 ºC and autosampler temperature 10 ºC. This method was validated according to ICH requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, LOD, LOQ, linearity and range. Linear relationships were obtained in the ranges of 10-300 µg/mL and 5-200 µg/mL with correlation coefficients of 0.9997 and 0.9998 for Amlodipine Besylate and Valsartan respectively. The forced degradation studies as acidity, alkalinity, oxidation, heat, thermal, humidity and photodegradation were performed according to ICH guidelines. UR - http://www.ajchem-a.com/article_88423.html L1 - http://www.ajchem-a.com/article_88423_4a98671cfbe3639a7b3debbdedb77c94.pdf ER -