ANALYTICAL UHPLC METHOD FOR SOLID DOSAGE FORM ANALYSIS OF TAMSULOSIN AND DEFLAZACORT: DEVELOPMENT AND VALIDATION

Sathish Kumar G.*, Vijayamirtharaj R., Senthil Kumar N.

ABSTRACT

To treat various medical conditions, the pharmaceutical compounds Deflazacort and Tamsulosin are commonly used in solid dosage forms. As an antagonist of the alpha-1 adrenergic receptor, Tamsulosin can effectively treat BPH and lower urinary tract symptoms. Inflammatory and autoimmune conditions are treated with Deflazacort, a synthetic glucocorticoid. An RP-HPLC based method was developed and validated for estimating Tamsulosin and Deflazacort in a combined dosage form simultaneously. With UHPLC, separation efficiency is improved, solvent consumption is reduced, and analysis is rapid as compared with conventional chromatography. Assays revealed that Deflazacort had an average percentage purity of 100.24%, and Tamsulosin had an average percentage purity of 100.50%, with coefficients of variation of 0.71 and 0.27, respectively. The validation parameters all met ICH requirements, with a plate count exceeding 1000 and a tailing factor below 2. Deflazacort and Tamsulosin were injected in duplicate at five linear concentrations. Tamsulosin's linearity equation was y = 0.2195x + 0.06119, while Deflazacort's linearity equation was y = 0.903x - 0.0634, both with high correlation coefficients (R2 = 0.9999). Three levels of accuracy samples were used to evaluate the accuracy of the standard addition method. Triplicate injections were performed for each level, resulting in mean % recovery ranging from 99.63% to 100.90% for Tamsulosin and 99.80% to 100.90% for Deflazacort. Tamsulosin % RSD was 0.50% and Deflazacort % RSD was 0.21%, respectively. It was confirmed that the method is specific since no interfering peaks were detected in placebo or blank samples during retention times for the target drugs. Flow rate and wavelength variations were introduced to assess robustness conditions, with minimal impact on system suitability parameters, keeping all parameters within acceptable limits. A RP-HPLC method was developed to estimate Tamsulosin and Deflazacort simultaneously in a combined dosage form, and it was shown to be rapid, specific, sensitive, precise, and accurate. A valuable tool for routine analysis and research, this method is suitable for use in various fields like pharmaceutical analysis, quality control, and biopharmaceutics.

Keywords: UHPLC, Tamsulosin, Deflazacort, Validation, Analytical methods.