EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

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.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia