A NEW STABILITY-INDICATING RP-HPLC-PDA METHOD FOR SIMULTANEOUS ESTIMATION OF TRIPLICATE MIXTURE OF RAMIPRIL, ATORVASTATIN AND CLOPIDOGREL IN TABLET DOSAGE FORM


Subba Rao, B. Balaswami, P. Venkata Ramana, P. Sanjeeva, G. Srenivasulareddy

Abstract


Objective: To develop a novel, accurate, precise and linear reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous quantitative estimation of ramipril, atorvastatin and clopidogrel in Atamra-CV tablet and validate as per international conference on harmonization (ICH) guidelines and to perform the force degradation studies using the developed method.

Methods: In the present work, the good chromatographic separation was achieved isocratically using a shim-pack HPLC Kromasil 150 mm x 4.6 mm, 5 m. m. And mobile phase consisting of 0.05 M potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid and acetonitrile in the ratio (52:48), at flow rate 1 ml/min and column temperature (30 °C). The effluents obtained were monitored at 210 nm with the UV-visible detector.

Results: The retention time of ramipril, atorvastatin and clopidogrel was found to be 2.893 min, 5.012 min and 6.102 min respectively. The linearity of ramipril, atorvastatin and clopidogrel was found in the range of 25-150 % and the correlation coefficient for ramipril, atorvastatin and clopidogrel were>0.999. The high recovery values (98%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveals that the method is precise. The three-drug samples were subjected to stress conditions of acidic and alkaline hydrolysis, oxidation, photolysis and thermal degradation. The proposed method proved to be stability-indicating by resolution of the analytes from their forced-degradation products.

Conclusion: The developed method is novel, simple, precise, rapid, accurate and reproducible for simultaneous estimation of ramipril, atorvastatin and clopidogrel tablet dosage form. Hence the proposed method may find practical applications as a quality-control tool in the simultaneous analysis of the three drugs in combined dosage forms in quality-control laboratories. The proposed method was made use of photodiode array (PDA) as a tool for peak identification and purity confirmation.


Keywords


ramipril, atorvastatin, clopidogrel, RP-HPLC method development, Validation,

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About this article

Title

A NEW STABILITY-INDICATING RP-HPLC-PDA METHOD FOR SIMULTANEOUS ESTIMATION OF TRIPLICATE MIXTURE OF RAMIPRIL, ATORVASTATIN AND CLOPIDOGREL IN TABLET DOSAGE FORM

Keywords

ramipril, atorvastatin, clopidogrel, RP-HPLC method development, Validation,

DOI

10.22159/ijap.2018v10i5.26945

Date

08-09-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 10, Issue 5 (Sep-Oct), 2018 Page: 90-96

Online ISSN

0975-7058

Authors & Affiliations

Subba Rao
Department of chemistry, Sri Krishnadevaraya University, Ananthapuramu 515003, A.P, India
India

B. Balaswami
Department of chemistry, Sri Krishnadevaraya University, Ananthapuramu 515003, A.P, India
India

P. Venkata Ramana
Department of chemistry, Sri Krishnadevaraya University, Ananthapuramu 515003, A.P, India
India

P. Sanjeeva
Department of chemistry, Sri Krishnadevaraya University, Ananthapuramu 515003, A.P, India

G. Srenivasulareddy
Department of chemistry, Sri Krishnadevaraya University, Ananthapuramu 515003, A.P, India


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