Development and Validation of Rilpivirine in Pharmaceutical Formulation by RP-HPLC

American Journal of PharmTech Research

article

B M S Kumar¹  B. Rajkamal²  B. Chandramowli¹ 

[1] Research Scholar, Mewar University;Research Supervisor, Mewar University

关键词: Rilpivirine;    Anti HIV agent;    RP-HPLC;    system suitability;    linearity;    recovery studies;   

DOI  :  10.46624/ajptr.2019.v9.i3.029

学科分类：药学

来源: American Journal Of Pharmtech Research

【 摘 要 】

In the present study a simple isocratic reverse phase HPLC method was developed for the estimation of rilpivirine in pharmaceutical formulation. The separation was carried out using a column of Zorbax Eclipse XDB-C18, 250x4.6mmi.d with 5micron particle size. The mobile phase comprises of 0.03M di potassium hydrogen orthophosphate with pH adjusted to 2.5 using dilute ortho-phosphoric acid (mobile phase solvent-A) and acetonitrile (mobile phase solvent-B) in the ratio of 15: 85 (v/v).The flow rate was 1.0 ml/min and the effluents were monitored at 284 nm. The retention time was 7.19 min. The detector response was linear in the concentration range of 100-300µg/ml. The respective linear regression equation being Y= 28817.742X-14741.2. The limit of detection (LOD) and limit of quantification (LOQ) for rilpivirine were found to be 0.05µg/ml and 0.15 µg/ml respectively. The assay was found to be 99.85%.The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of rilpivirine in its pharmaceutical dosage form.

【 授权许可】

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