Abstract
The objectives of this study were both to develop, optimize and validate
spectrophotometric and chromatographic methods for the analysis of amlodipine
besylate and esomeprazole magnesium in pharmaceutical formulations in presence of
their degradation products and to study their stability under various conditions.
The spectrophotometric method for amlodipine was based on either its solubility
enhancement using different hydrotropic agents including potassium acetate, ammonium
acetate and nicotineamide, or on its formation of ion-pair complex with methyl orange at
pH 3.5, showing percentage recovery ranges of 99.74 – 100.04 and 99.82 – 101.05,
respectively. For esomeprazole magnesium, the method, however, was based either on
its reaction with alizarin red s to form a deep brown complex, or on its formation of ionpair
complex with eriochrome black T at pH 3, showing percentage recoveries ranges of
99.53 – 100.45 and 99.57- 100.52, respectively. These recovery results indicated that
both developed spectrophotometric methods for each drug were highly accurate.
The development of the liquid chromatographic methods for each drug, however, was
based on the application of the factorial design approach, and they were all performed at
ambient temperature; for amlodipine besylate, the mobile phase used was composed of
either of acetonitrile and water (60:40 v/v) in presence of 0.1% triehylamine or of 20
mM potassium dihydrogen phosphate, flowing at a rate of either 1.0 or 1.5 ml/min,
through column C18 column (containing 5μm- size particle) of dimensions 250× 4.5 mm
or 150× 4.6 mm, respectively at wavelength either 362 or 212 nm, giving recovery
percentage of either 99.96 – 100.54 or 99.76 – 101.13, respectively. For esomeprazole
magnesium, the mobile phase used was composed of water and either methanol (60:40)
or ethanol (45:55), flowing at the same flow rate of 1.0 ml/min for both methods,
through either column C12 (150× 4.5 mm) or column C18 column (150× 4.6 mm), both
containing 5μm-size particles, respectively at 302 nm wavelength for both methods, and
giving percentage recovery range of 99.90 – 100.26 and 99.43 – 100.78, respectively.
These recovery results for both developed chromatographic methods for each drug were
also highly accurate.
It was found that stability of both drugs was affected by several factors including
hydrolysis, heat, and sunlight. The kinetic study of the effect of sunlight, thermal
hydrolysis, hydrolysis in alkaline medium and effect of heat on the stability of
amlodipine besylate revealed that the reaction was zero, second, zero and first order,
respectively. That of the effect of sunlight, thermal hydrolysis, hydrolysis in acidic
medium and heat on the stability of esomeprazole magnesium revealed that the reaction
was zero, zero, first and zero order, respectively.
Ahmed, M (2021). Design and validation of chromatographic and spectrophotometric stability indicating methods for determination of amlodipine besylate and esomeprazole magnesium. Afribary. Retrieved from https://afribary.com/works/design-and-validation-of-chromatographic-and-spectrophotometric-stability-indicating-methods-for-determination-of-amlodipine-besylate-and-esomeprazole-magnesium
Ahmed, Makka "Design and validation of chromatographic and spectrophotometric stability indicating methods for determination of amlodipine besylate and esomeprazole magnesium" Afribary. Afribary, 02 Jun. 2021, https://afribary.com/works/design-and-validation-of-chromatographic-and-spectrophotometric-stability-indicating-methods-for-determination-of-amlodipine-besylate-and-esomeprazole-magnesium. Accessed 08 Oct. 2024.
Ahmed, Makka . "Design and validation of chromatographic and spectrophotometric stability indicating methods for determination of amlodipine besylate and esomeprazole magnesium". Afribary, Afribary, 02 Jun. 2021. Web. 08 Oct. 2024. < https://afribary.com/works/design-and-validation-of-chromatographic-and-spectrophotometric-stability-indicating-methods-for-determination-of-amlodipine-besylate-and-esomeprazole-magnesium >.
Ahmed, Makka . "Design and validation of chromatographic and spectrophotometric stability indicating methods for determination of amlodipine besylate and esomeprazole magnesium" Afribary (2021). Accessed October 08, 2024. https://afribary.com/works/design-and-validation-of-chromatographic-and-spectrophotometric-stability-indicating-methods-for-determination-of-amlodipine-besylate-and-esomeprazole-magnesium