ACTA Pharmaceutica Sciencia 2021 , Vol 59 , Num 3
Stability Indicating Method Development and Validation of Ranolazine Extended Release Tablets
Evin Aycicek DURAK 1 İbrahim KURTGÖZ 2 Burcu MESUT 1 Erdal CEVHER 1 Yıldız ÖZSOY 1
1 Istanbul University, Faculty of Pharmacy, Pharmaceutical Technology Dept., Beyazıt, Istanbul, Turkey
2 Biopharma Pharmaceutical, Istanbul, Turkey
DOI : 10.23893/1307-2080.APS.05925 The objective of this study was to develop and validate the stability-indicating method for newly developed Extended-Release tablet formulation of Ranolazine. First, new Ranolazine tablet formulation was developed. These tablets were analyzed by using a High-Performance Liquid Chromatography system with a UV detector at 220 nm wavelength and by using C8-3 column (150 mm x 4.6 mm i.d; 5 µm particle size). The injection volume of the system was 10 µl. The validation parameters; Selectivity, linearity, accuracy, robustness, precision and limit of quantification and detection parameters were proved good results. A highly sensitive and simple HPLC-UV analytical method of the Ranolazine tablet formulation was developed in accordance with ICH Guideline Q2 and Q3. Keywords : Ranolazine, HPLC, forced degradation, stability indicating method, validation

Istanbul Medipol University