STABILITY INDICATING ANALYTICALMETHOD DEVELOPMENT AND VALIDATION OF ALFUZOSIN HYDROCHLORIDE AND TADALAFIL BY USING RP-HPLC

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H. Saraswathi; Dasari Vasavi Devi; Dr. D. Swarnalatha

STABILITY INDICATING ANALYTICALMETHOD DEVELOPMENT AND VALIDATION OF ALFUZOSIN HYDROCHLORIDE AND TADALAFIL BY USING RP-HPLC

Authors: H. Saraswathi, Dasari Vasavi Devi, Dr. D. Swarnalatha

Unique Paper ID: 181020
Volume: 12
Issue: 1
PageNo: 3680-3688

Keywords: HPLC Tadalafil Alfuzosin HCl specificity purity and ICH guidelines. ABBREVATIONS: HPLC-High performance liquid chromatography HCL-Hydrochloric Acid

Abstract:
A simple, accurate, sensitive, and repeatable reverse phase high performance liquid chromatography (RP-HPLC) method has been created to measure s amount of Tadalafil and Alfuzosin HCl in medicinal dosage form. For the chromatographic separation of Tadalafil and Alfuzosin HCl on the Waters Alliance-e2695, a Luna Phenyl Hexyl (250x 4.6mm, 5µ) column was used, and the mobile phase was made up of 30:70% v/v Acetonitrile, Ammonium acetate pH-3.0, and OPA. The flow rate was 1 ml/min, and a photodiode array detector working at room temperature was used for absorption at 294nm. In the case of Tadalafil, the number of potential plates was NLT 2000, and the tailing factor should not be more than 2. It is always less than 2.0 for the relative standard deviation of peak areas across all measures. Following ICH guidelines, the suggested method was proven to work. It was discovered that the method was easy, cheap, accurate, exact, and strong for studying the stability of Tadalafil and Alfuzosin HCl in large amounts.

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Cite This Article

ISSN: 2349-6002
Volume: 12
Issue: 1
PageNo: 3680-3688

STABILITY INDICATING ANALYTICALMETHOD DEVELOPMENT AND VALIDATION OF ALFUZOSIN HYDROCHLORIDE AND TADALAFIL BY USING RP-HPLC

Available:https://ijirt.org/article?manuscript=181020

Impact Factor
8.01 (Year 2024)

UGC Approved
Journal no 47859

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