Int. J. Chem. Sci.

: 7(1), 2009, 216-218

SPECTROPHOTOMETRIC ESTIMATION OF
CLOPIDOGREL BISULPHATE IN PHARMACEUTICAL
DOSAGE FORMS
NAYANA PIMPODKARa∗∗, YOGITA SHETE, N. S. MAHAJANa,
Y. V. PORE, R. L. JADHAVa and B. S. KUCHEKAR

Government College of Pharmacy, Vidyanagar, KARAD – 415214, Dist., Satara (M. S.) INDIA
a
Department of Pharmaceutical Chemistry, Satara College of Pharmacy, SATARA (M. S.) INDIA

ABSTRACT
A simple, sensitive, rapid, accurate and precise spectrophotometric method has been developed
for estimation of clopidogrel bisulfate in bulk and pharmaceutical dosage forms. clopidogrel bisulfate
shows maximum absorbance at 270 nm with molar absorptivity of 848.3 × 103 L/mol. cm. Beer’s law
was obeyed in the concentration range of 50 – 500 µg/mL. Results of analysis were validated statistically
and by recovery studies.

Key words : Clopidogrel bisulfate, Spectrophotometric method.

INTRODUCTION

clopidogrel bisulfate is chemically known as methyl (+)-(S)-α-(2-chlorophenyl) -6,

7-dihydrothieno [3, 2-c] pyridine-5(4H)-acetate sulfate (1 : 1). It is a new thienopyridine
derivative chemically related to ticlopidine1,2 It prevents ischemic stroke, myocardial
infraction and vascular disease and is indicated for the reduction of atherosclerotic
events3, 4. It is official in Merck index and Martindale. Only HPLC methods are reported
for estimation of clopidogrel bisulphate in formulation and its metabolites in plasma and
serum. Gas chromatographic determination of clopidogrel from tablet dosage forms has
been reported5-7.

The objective of this study was to develop simple, rapid, accurate and specific
spectrophotometric method for the estimation of clopidogrel bisulfate using UV
spectrophotometer. The simple method was developed using solvent distilled water with

∗
Author for correspondence; E-mail: pnayanv@yahoo.co.in
Int. J. Chem. Sci.: 7(1), 2009 217

minimum processing steps. The λmax of clopidogrel bisulfate in 0.1N H2SO4 was found to
be 270 nm and Beer’s law was obeyed in the range of 50–500 µg/mL. The result of
analysis was validated statistically and by recovery studies; thus, this method of estimation
of clopidogrel bisulfate was found to be simple precise and accurate.

EXPERIMENTAL

A Shimadzu 1700 UV spectrophotometer with 1 cm matched cuvetts was used for

estimation. Standard solution of drug, 1000 µg/mL was prepared in 0.1N H2SO4

Sample solution: Twenty tablets of clopidogrel bisulfate were weighed and

powered in glass mortar. Amount equivalent to 20 mg was transferred to 100 mL
volumetric flask, dissolved and made up the volume with 0.1N H2SO4

Aliquots of 1 to 10 mL portions of standard solution were transferred to a series of

10 mL Corning test tubes and volume in each test tube was adjusted to 10 mL with 0.1N
H2SO4. The absorbance of solutions was measured at 270 nm against 0.1N H2SO4 as a
blank and calibration curve was constructed. Similarly, absorbance of sample solution was
measured and amount of clopidogrel bisulfate was determined by referring to the
calibration curve. Recovery studies were carried out by adding a known quantity of pure
drug to the preanalyzed formulation and the proposed method was followed. From the
amount of drug found, percentage recovery was calculated.

RESULTS AND DISSCUSION

The proposed method of determination of clopidogrel bisulfate showed molar

absorptivity of 848.3 × 103 L/mol. cm and Sandell’s sensitivity 0.4949 mcg/cm2/0.001-
absorbance units. Linear regression of absorbance on concentration gave the equation y =
0.00202 x + 0.00373 with a correlation coefficient of 0.9998. Relative standard deviation
of 0.14232 was observed for analysis of three replicate samples, indicating precision and
reproducibility.

clopidogrel bisulfate exhibits its maximum absorption at 270 nm and obeyed

Beer’s law in the range of 50 – 500 µg/mL. The results of analysis and recovery studies are
presented in the Table 1. The percentage recovery value 99-100% indicates that there is no
interference from the excipients present in formulation. The developed method was found
to be sensitive, accurate, precise and reproducible and can be used for the routine quality
control analysis of clopidogrel bisulfate in bulk drugs and formulations.
218 N. Pimpodkar et al.: Spectrophotometric….

Table 1 : Results of analysis and recovery studies

Formulations Label % S. D. C. O. V. S. E. %
Claim Estimated (%) Recovery
Tab 1 75 99.42 0.81 0.82 0.47 100.47
Tab 2 75 100.49 1.20 1.19 0.69 99.48
Tab 3 75 100.20 0.90 0.90 0.52 99.73
S. D : Standard Deviation, S. E. : Standard Error, C. O. V. : Coefficient of
Variation

ACKNOWLEDGEMENTS

We are grateful to Torrent Pharmaceutical Ltd., Mehsana, Gujarat, for providing

gift sample of drug for research work. We are also thankful to Principal, Govt. College of
Pharmacy, Karad for providing laboratory facility and constant encouragement.

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Revised : 25.10.2008 Accepted : 01.11.2008