Stability Indicating Simultaneous Equation Method for Determination of Domperidone and (S)-Esomeprazole Magnesium in Capsule Dosage Form Using UV-Spectrophotometer

Abstract

Aims: Stability indicating simultaneous equation method for determination of Domperidone and Esomeprazole Magnesium in capsule dosage form using UV-Spectrophotometry. Study Design: A new simultaneous equation method was developed and validated for the determination of esomeprazole magnesium and domperidone in capsule dosage form. Place and Duration of Study: Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly, Uttar Pradesh during July 2012 to June 2013. Methodology: Simultaneous equation method was performed for estimation of dosage form and degradants. Results: The maximum wavelength (λmax) was found to be 299 nm for esomeprazole magnesium and 287 nm for domperidone. The linearity range was found to be 1-6 µg ml-1 (r2= 0.998) and 5-30 µg ml-1 (r2= 0.999) for esomeprazole magnesium and domperidone, respectively. The value of limit of detection and limit of quantification was 0.116 and 0.386 µgml-1 for esomeprazole magnesium and 0.657 and 2.18 µgml-1 for domperidone, respectively. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline. Conclusion: This study shows that the proposed spectrophotometric method is useful for the routine determination of esomeprazole magnesium and domperidone in its combined pharmaceutical dosage form.