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Stability Indicating Absorption Ratio Method for Determination of Domperidone and Esomeprazole Magnesium in Capsule Dosage Form Using UV-Spectrophotometer


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1 Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
     

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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 (&#955; max) 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 1-6 μg ml<SUP>-1</SUP>(r<SUP>2</SUP>= 0.998) and 5-30 &#181;g ml<SUP>-1</SUP>(r<SUP>2</SUP>= 0.999) for ESO and DOM respectively. The value of limit of detection and limit of quantification was 0.116&#181;gml<SUP>-1</SUP> and 0.386&#181;gml-1 for ESO and 0.657&#181;gml<SUP>-1</SUP> and 2.18&#181;gml<SUP>-1</SUP> 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.

Keywords

Esomeprazole Magnesium, Domperidone, Spectrophotometric Method, Forced Degradation Studies, Absorption Ratio Method
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  • Stability Indicating Absorption Ratio Method for Determination of Domperidone and Esomeprazole Magnesium in Capsule Dosage Form Using UV-Spectrophotometer

Abstract Views: 358  |  PDF Views: 2

Authors

Jyoti Rai
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
Sunil Singh
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
Inamullah
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
Nisha Choudhary
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
Surabhi Sharma
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)
Hemendra Gautam
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly (U.P.)

Abstract


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 (&#955; max) 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 1-6 μg ml<SUP>-1</SUP>(r<SUP>2</SUP>= 0.998) and 5-30 &#181;g ml<SUP>-1</SUP>(r<SUP>2</SUP>= 0.999) for ESO and DOM respectively. The value of limit of detection and limit of quantification was 0.116&#181;gml<SUP>-1</SUP> and 0.386&#181;gml-1 for ESO and 0.657&#181;gml<SUP>-1</SUP> and 2.18&#181;gml<SUP>-1</SUP> 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.

Keywords


Esomeprazole Magnesium, Domperidone, Spectrophotometric Method, Forced Degradation Studies, Absorption Ratio Method

References