RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF NIACIN AND SIMVASTATIN IN TABLET DOSAGE FORM

被引：0

作者：

Mulagada, Gowri Manoja ^{[1
]}

Sridevi, S. ^{[1
]}

Devi, M. Gayathri ^{[2
]}

Kumar, Mukalla Ganesh ^{[1
]}

机构：

[1] Srinivasarao Coll Pharm, Visakhapatnam 530041, Andhra Prades, India

[2] Viswanadha Inst Pharmaceut Sci, Visakhapatnam 531173, Andhra Prades, India

来源：

INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES | 2018年 / 5卷 / 02期

关键词：

Niacin; Simvastatin; RP-HPLC; Method Development; Validation; ICH guidelines;

D O I：

10.5281/zenodo.1183739

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

A simple RP-HPLC method has been developed for the simultaneous estimation of Niacin and Simvastatin in tablet dosage form. Chromatographic separation was achieved on Hypersil BDS C18 (250 x 4.6 mm, 5m column using Acetonitrile and Ammonium dihydrogen phosphate buffer in the ratio of 80:20 v/v, pH 5, with flow rate of 1 ml/min. The detection wavelength was set at 254 nm. The retention time of niacin was 2.0852 and simvastatin was found to be 5.7052. The method was applied to tablet dosage forms, without any interference from excipients. The calibration curve was linear over the range of 20-120 ug/ml. The performance of the method was validated according to ICH guidelines and it was found suitable for the analysis of Niacin and Simvastatin in tablet dosage forms.

引用

页码：1007 / 1012

页数：6

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