A STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SIMVASTATIN AND NIACIN IN A COMBINED DOSAGE FORM


Jeyashanthini Nalaiya, Sreenivasa Rao Sagineedu, Rajakumari Rajasingam, Zawahil Kassim, Mallikarjuna Rao Pichika

Abstract


Objective: To develop a simple, selective and rapid stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method and validate as per ICH guidelines for simultaneous determination of simvastatin and niacin in a combined dosage form.

Methods: The chromatographic separation of the two cholesterol lowering drugs were achieved using Inertsil CN (5 µm, 250 mm x 4.6 mm i. d. column), maintained at 30 °C throughout the analysis. The drugs were separated in isocratic elution mode with a mobile phase of 0.1% acetic acid buffer-methanol (50:50, v/v) at a flow rate of 1.0 mL/min and a detection wavelength of 237 nm using a UV-PDA detector.

Results: The linearity and range for niacin and simvastatin were 0.05 to 0.150 mg/mL (R2> 0.9999) and 0.004 to 0.012 mg/mL (R2> 0.9992), respectively. Mean recoveries observed for niacin and simvastatin were 99.36% and 99.93%, respectively. The precision of the method obtained was 99.66% for niacin and 99.34% for simvastatin with a relative standard deviation less than 2%. The lower degree of % RSD that was obtained for intermediate precision has proved that the method is robust and rugged.

Conclusion: A simple and rapid stability-indicating RP-HPLC method was developed and validated for simultaneous determination of niacin and simvastatin in a combined dosage form and hence, it can be used in the quality control analysis of an active pharmaceutical ingredient and pharmaceutical dosage form.

 


Keywords


Simvastatin, Niacin, RP-HPLC, Stability, Validation

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About this article

Title

A STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SIMVASTATIN AND NIACIN IN A COMBINED DOSAGE FORM

Keywords

Simvastatin, Niacin, RP-HPLC, Stability, Validation

Date

19-12-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 7, Issue 2, 2015 Page: 262-268

Online ISSN

0975-1491

Statistics

394 Views | 201 Downloads

Authors & Affiliations

Jeyashanthini Nalaiya
International Medical University
Malaysia

Sreenivasa Rao Sagineedu
International Medical University
Malaysia

Rajakumari Rajasingam
International Medical University
Malaysia

Zawahil Kassim
Innovax Sdn.Bhd
Malaysia

Mallikarjuna Rao Pichika
International Medical University
Malaysia


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