Study on Development and Validation of Stability Indicating RP-HPLC Method for Guaifenesin

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Study on Development and Validation of Stability Indicating RP-HPLC Method for Guaifenesin

September 6, 2021 Pharmaceutical 0

A simple, accurate, and exact stability indicating RP HPLC technique was developed and validated for the determination of Guaifenesin in bulk and formulation. Under various forced degradation settings, the drug and its breakdown products were separated on a Phenomenex C18 column (250 4.6 mm, 5) using a mobile phase of methanol:water (60:40 percent v/v). The flow rate was kept constant at 1.0 mL/min and the eluents were detected at 230 nm. In forced degradation testing, guaifenesin deteriorated in acid, alkali, photolytic, and wet heat environments, but remained stable in H2O2 (oxidative) and dry heat environments. In calibration curve investigations, linearity was discovered in the concentration range of 2-12 g/mL, with a regression coefficient (R2) of 0.999. y = 102800 x + 24264 was the equation found. For the determination of guaifenesin, a rapid, simple, sensitive, and accurate HPLC –UV approach has been described. It may be deduced from the forced degradation investigations that guaifenesin is degraded by acid, alkali, moist heat, and photolysis.

Author (S) Details

Sandhya R. Gawai
Department of Quality Assurance, MET Institute of Pharmacy, Nasik, Maharashtra, India.

Kiran Gadge
Department of Quality Assurance, MET Institute of Pharmacy, Nasik, Maharashtra, India.

Sandeep Sonwane
Department of Quality Assurance, MET Institute of Pharmacy, Nasik, Maharashtra, India.

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