Abstract

  A stability indicating High Performance Thin Layer Chromatography (HPTLC) was developed for the simultaneous estimation of Levosulpiride and Ilaprazole in bulk and capsule dosage form. The chromatographic conditions were optimized using Design of Experiment (DoE); where in the critical factors for separation of both drugs were identified using Taguchi design. Further, optimization was done using Central Composite design and it was then subjected to forced degradation study. The separation was achieved using mobile phase Toluene: Ethyl acetate: Methanol: Tri ethyl amine (TEA) (4.52: 2.5: 2.02: 0.2% v/v/v/v) with Rf values of 0.46 and 0.71 for Levosulpiride and Ilaprazole respectively. Linearity was observed in the concentration range of 3750-22500 ng/band for Levosulpiride and 500-3000 ng/band for Ilaprazole. Developed method was validated according to ICH guidelines. The developed method can be used for separation and simultaneous estimation of aforesaid drugs in capsule dosage form as well as in presence of degradation products.

Keywords:Central Composite Design; Levosulpiride; Ilaprazole; HPTLC; Stability Indicating

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Citation

Citation: Archita J Patel., et al. “Development and Validation of Stability Indicating Method for Simultaneous Estimation of Ilaprazole and Levosulpiride in Bulk and Capsules Using Design of Experiment Approach". Acta Scientific Pharmaceutical Sciences 4.2 (2020): 15-23.