¹Department of Quality Assurance, Student of Bharati Vidyapeeth’s College of Pharmacy, University of Mumbai, Navi Mumbai, India
²Department of Pharmaceutics, Associate Professor of Pharmaceutics Bharati Vidyapeeth’s College of Pharmacy, University of Mumbai, Navi Mumbai, India
³Department of Pharmaceutics, Vice-principal of Bharati Vidyapeeth’s College of Pharmacy, University of Mumbai, Navi Mumbai, India DOI : 10.29228/jrp.545 The current study describes a Q- Absorption Ratio spectrophotometric method development and validation for the simultaneous determination of esomeprazole magnesium and ondansetron hydrochloride. The concentration of the drugs was determined by using the ratio of absorbance at the iso-absorptive point (λ₁ = 275 nm) and the λ_max of esomeprazole magnesium (λ₂ = 302 nm). This method is linear for both drugs in the range of 5–25 μg/mL at λ₁ (R² = 0.999) and at λ₂ (R² = 0.9998) for ondansetron hydrochloride, and esomeprazole magnesium found at λ₁ (R² = 0.9995) and λ2 (R² = 0.9997). According to ICH recommendations Q2(R1), statistical analysis and recovery studies have been used to validate the analysis findings. The % Recovery was 97.78% – 100.81 % of ondansetron and 100.33% – 102.03 % of esomeprazole by the standard addition method. The method was found to be precise as the % relative standard deviation was less than 2.00 in interday and intraday precision for ondansetron and esomeprazole. The results of the current study indicated that the developed method is simple, linear, precise, accurate, and sensitive, hence may be used for quality control purposes. Keywords : Ondansetron hydrochloride; esomeprazole; UV-spectrophotometer; validation; accuracy; precision