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 UVSpectrophotometry. 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.