METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USP
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Keywords
HPLC, Method validation, Method development, ICH, Oral Suspension
Abstract
A brand-new, regulatory-based HPLC technique has been created and approved for use in the USP oral suspension assay of trimethoprim and sulfamethoxazole.Using waters X-bridge shield C-18, 4.6 mm x 100 mm, 3.5 μm, HPLC separation was accomplished buffer pH 5.5 and methanol (75:25) were used in the mobile phase proportion, with a flow rate of 1.2 ml/min. The 220 nm wave length, 20 μL injection volume, 50°C column temperature, and 2 5°C sampler temperature were used for the detection. Sulfamethoxazole and trimethoprim had retention times of roughly 2.2 and 2.9 minutes, respectively.Run time about 8 minutes. According to ICH criteria, the developed procedures have undergone validation. The technique demonstrated satisfactory results in terms of robustness, ruggedness, linearity, specificity, and precision. The USP approach and the suggested procedure were proven to be equal.
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Nataraj Palaniyappan
Research scholar, Department of Pharmacy, JJT University, Jhunjhunu, Rajasthan, India
Satish Pavuluri
Associate Professor, Department of Pharmacy, JJT University, Jhunjhunu, Rajasthan, India
T. Venkatachalam
Department of Pharmaceutical Chemistry, JKK Munirajaha Medical Research Foundation College of Pharmacy, B.Komarapalayam - 638183, Namakkal (DT), Tamil Nadu, India.