Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
*Corresponding Author E-mail: rssunil29@rediffmail.com
Online published on 21 September, 2013.
A new stability indicating absorption ratio method was developed and validated for the determination of Esomeprazole magnesium (ESO) and Domperidone (DOM) in capsule dosage form. The maximum wavelength (λmax) was found to be 299nm for ESO and 287nm for DOM. The iso-absorptive point of both the drug was found to be 290 nm. The linearity range was found to be 1–6μgml−1(r2=0.998) and 5–30μgml−1(r2=0.999) for ESO and DOM respectively. The value of limit of detection and limit of quantification was 0.116μgml−1 and 0.386μgml−1 for ESO and 0.657μgml−1 and 2.18μgml−1 for DOM respectively. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per ICH guideline. The result of study showed that the proposed spectrophotometric method is useful for the routine determination of ESO and DOM in its combined pharmaceutical dosage form.
Esomeprazole magnesium, domperidone, spectrophotometric method, forced degradation studies, absorption ratio method