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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SODIUM PHENYLBUTYRATE AND TAURURSODIOL

Author(s) H. Padmalatha
Country India
Abstract Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Sodium Phenylbutyrate and Taurursodiol in pharmaceutical dosage form.
Methods: Chromatogram was run through Phenomene x C 18 column (150x4.6mm, 5µm). Mobile phase containing Buffer: ACN:Methanol (30:5:65) pH 3.5 was pumped through column at a flow rate of 1.2 ml/min. Buffer used at pH 3.5. Temperature was maintained at Ambient. Optimized wavelength for Sodium Phenylbutyrate and Taurursodiol was 249 nm.
Results: Retention time of Sodium Phenylbutyrate and Taurursodiol were found to be 5.04 min and 9.71 min. The % purity of Sodium Phenylbutyrate and Taurursodiol was found to be 100.03 % and 99.75 % respectively. The system suitability parameters for Sodium Phenylbutyrate and Taurursodiol such as theoretical plates and tailing factor were found to be 4836,0.97 and 3568, 1.42. the resolution was found to be 8.0. The linearity study for Sodium Phenylbutyrate and Taurursodiol was found in concentration range of 5μg-15 μg and 200 μg-600 μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.19 % and 100.84 %, %RSD for repeatability was 0.75 and 0.36 %. The precision study was precise, robust and repeatable. LOD value was 0.08 and 0.25, and LOQ value was 1.08 and 0.35 respectively
Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Sodium Phenylbutyrate and Taurursodiol in pharmaceutical dosage form.
Keywords Sodium Phenylbutyrate, Taurursodiol, RP‐HPLC, Simultaneous estimation
Field Medical / Pharmacy
Published In Volume 16, Issue 11, Array 2025
Published On 2025-11-07
Cite This DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SODIUM PHENYLBUTYRATE AND TAURURSODIOL - H. Padmalatha - IJTAS Volume 16, Issue 11, Array 2025.
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