Sanju Srinivas1, Marium Nazneen2
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana
2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana
A B S T R A C T
A new method was established for simultaneous estimation of Lansoprazole and Domperidone by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Lansoprazole and Domperidone by using Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Lansoprazole and Domperidone was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was0.7 and 0.4, %RSD for intermediate precision was 0.18 and 0.39 respectively.
Keywords: Lansoprazole, Domperidone, RP-HPLC, validation.