Simultaneous quantification of mometasone furoate and formoterol fumarate in bulk and formulations by RP-HPLC method Sivagami B1,*, Bhaskar M1, Kumar Pavan V1, Meena D1, Kumar Satheesh G2, Chandrasekar R2 1Associate Professor, Faculty of Pharmacy Pharmaceutical Sciences, Department of Pharmaceutical Analysis, Seven Hills College of Pharmacy, Venkatramapuram, Tirupati, Chittoor, Andhra Pradesh, India 2PG Student, Pharmaceutical Sciences, Department of Pharmaceutical Analysis, Seven Hills College of Pharmacy, Venkatramapuram, Tirupati, Chittoor, Andhra Pradesh, India *Corresponding Author E-mail: sivagamib_27@rediffmail.com
Online Published on 23 January, 2024. Abstract A simple and robust reversed-phase high pressure liquid chromatographic method was developed and validated for the quantification of Mometasone and Formoterol in bulk and fixed dosage forms. The column utilized for study was Inertsil C18, ODS was chosen for good peak shape. Ambient temperature was found to be suitable for the nature of drug solution. The mobile phase was streamlined with a ratio of 35:65 Methanol: Water was optimized for symmetrical peaks and good resolution. The flow rate was streamlined at 1.0 ml/min because of good peak area, satisfactory retention time and good resolution. Common λ-max was found to be at 278 nm and Injection volume was 20 μl which gave a good peak area. The percentage recovery was found to be 98.0-101.50 was linear and precise over the same range. Both system and method precision was found to be accurate and well within the acceptable limits. Detection limit was found to be 0.25 Mometasone and 0.34 for Formoterol. The analytical method was found linearity over the range of 20-80 ppm of the target concentration for both the drugs. The LOD and LOQ values for Mometasone, was observed to be 0.25 and 0.77 and for Formoterol was in the range of 0.34 and 1.05 consecutively. The analytical method passed both intermediate precision and robustness tests. On both cases, relative standard deviation was well satisfactory. The validation experiments met ICH standards. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision. Top Keywords Mometasone Furoate, Formoterol Fumarate, Simultaneous Quantification, Validation. Top |