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Validated stability indicating spectroscopic method for estimation of degradation Behavior of Trimethoprim and Sulfamethoxazole in tablet formulation
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| Author:
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TUKARM KALYANKAR, TUKARAM M. KALYANKAR, SAGAR K. DAMKONDWAR, SANJAY S. PEKAMWAR
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| Abstract:
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A new simple, precise, accurate and reproducible stability indicating spectroscopic method for estimation of degradation Behavior of Trimethoprim (TRM) and Sulfamethoxazole (SMX) in tablet formulation. The TRM wavelength was selected 237 nm (zero crossing point of sulfamethoxazole) and 259 nm for SMX (zero crossing point of trimethoprim). Beer’s law obeyed in concentration range of 3-18 µg/ml and 15-90 µg/ml for TRM and SMX with the correlation coefficient (R2) of 0.999 for TRM and 0.998 for SMX respectively. % RSD for both drugs was found to be less than 2% for accuracy and precision, shows good compliance with ICH guidelines. The proposed method was validated for accuracy, precision, linearity, limits of detection (LOD), quantification (LOQ) and reproducibility and observations were found within the limit. The stability study was performed for drugs by using acid, base, neutral, hydrolysis, oxidation, thermal and photolytic degradations which indicates the stability indicating property of the method; thus the method is used for simultaneous estimation of TRM and SMX in combined dosage form.
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| Keyword:
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Trimethoprim (TRM), Sulfamethoxazole (SMX), ICH, UV spectroscopy
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| EOI:
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| DOI:
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