HPLC Analytical Method Development and Validation for Simultaneous Estimation of four Drugs: Sulfamethoxazole, Trimethoprim, Isoniazid and Pyridoxine hydrochloride Tablets

Abstract

The objective of this work is to design and verify a high-performance liquid chromatography technique for the simultaneous measurement of isoniazid, pyridoxine hydrochloride, trimethoprim, and sulfamethoxazole in pharmaceutical dosage forms. These medicines are essential parts of fixed-dose combination regimens used to prevent infections in HIV/AIDS patients. Experiments were conducted to find the optimal UV detector wavelength, column, and mobile phase composition as part of the technique optimisation. A Hypersil BDS C18 column was used to provide the chromatographic conditions, while methanol and potassium dihydrogen phosphate were used as the mobile phase. The procedure showed quick elution of all four medications in less than six minutes, proving its effectiveness in comparison to previous research. The International Council for Harmonisation (ICH) guidelines were followed in the validation process, which covered specificity, system appropriateness, linearity, accuracy, precision, robustness, and ruggedness. The new method's accuracy, precision, linearity, robustness, and ruggedness are demonstrated by the findings, which make it appropriate for regular drug analysis in pharmaceutical formulations. The method's effectiveness was assessed using commercial tablet samples, which showed that it could reliably measure the amount of medication in marketed goods. In summary, the established HPLC technique contributes to effective quality control and pharmaceutical analysis in the context of HIV/AIDS prophylaxis by providing a quick and dependable method for the simultaneous estimation of sulfamethoxazole, trimethoprim, isoniazid, and pyridoxine hydrochloride.