ABSTRACT

The prime essence of this current study is to develop a simple, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of Theophylline and Montelukast Sodium in bulk and pharmaceutical dosage form. The separation was achieved by using Hypersil BDS column, (150×4.6mm, particle size 5µ) with mobile phase containing 0.1% TFA: Acetonitrile: Methanol in the ratio 25:50:25 v/v/v at a flow rate of 0.7 mL/ min at detection of 250 nm. The developed method was validated according to ICH guidelines and was found to be linear, precise, accurate and robust. The linear response was observed in the range of 40-120 ?g/mL for Theophylline and 0.5-5 ?g/ mL for Montelukast Sodium. Method was precise with %RSD values of NMT 2 and was accurate with % recovery of 99.81% and 100.21% for Theophylline and Montelukast Sodium respectively. The method was robust enough to reproduce acceptable results under different method conditions. Upon performing the forced degradation studies for pharmaceutical dosage form, the % assay of formulation for acid, alkali, oxidative and thermal degradation was performed and the amount of degradation achieved was within the acceptance limits i.e., 5-20%. This method can be applied efficaciously for estimation of Theophylline and Montelukast Sodium quantitatively in the routine analysis and reliable for demonstrating and detecting any expected change or degradation in the drug product during stability studies. Keywords: RP-HPLC, Theophylline, Motelukast Sodium, Validation, Forced degradation studies
Publication date: 01/01/2022

https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_5842.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.1.5842