Informatics Publishing Limited

Jyoti Rai ¹, Sunil Singh ¹, Inamullah ¹, Nisha Choudhary ¹, Surabhi Sharma ¹, Hemendra Gautam ¹

Affiliations
1 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

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Nisha Choudhary ¹, Inamullah ¹, Sunil Singh ¹, Jyoti Rai ¹, Surabhi Sharma ¹

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

Abstract

An accurate, specific and precise new Absorption Ratio method was developed for the simultaneous determination of Lansoprazole and Naproxen. The method involved Q-absorption analysis based on the measurement of absorbance at two wavelengths, i. e max of Lansoprazole (284nm) and for Naproxen was (271nm) and Iso-absorptive point of both drugs (275nm). The linearity was found to be 10-35&#181;g/ml (r2 =0·999) for NAP and 5-30&#181;g/ml (r 2 =0·998) for LAN. Validation was performed as ICH guidelines for Linearity, accuracy, precision, LOD and LOQ. The limit of quantification of NAP was found to be 0·15&#181;g/ml and for LAN was 1·7&#181;g/ml. The limit of detection of NAP was found to be 0·04&#181;g/ml and for LAN was 0·5&#181;g/ml. The indicating proposed spectrophotometric method was accurate and precise for estimation of NAP and LAN in tablet dosage form

Keywords

Lansoprazole, Naproxen, Iso-absorptive Point

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