A simple, economical, precise and accurate method for simultaneous determination of Clopidogrel (CLOP) and Aspirin (ASP) in combined tablet dosage form has been developed. The first method is based on Ratio Spectra Derivative (Method A) and second method is based on Area under Curve (AUC) Spectrophotometry (Method B). The amplitudes 218.11 nm and 247.002 nm in the second derivative of the ratio spectra were selected for aspirin and clopidogrel respectively. In the second method (AUC) areas were integrated in the wavelength ranges between 215.66-218.78 nm and 235.15-238.27 with reference to the absorbance curves plotted between the wavelengths 200-350 nm to determine CLOP and ASP. The drugs obey Beer’s law in the concentration range of 5-25 µg mL-1 by both the methods. The methods were validated with respect to linearity, precision and accuracy. The results of analysis have been validated statistically and recovery studies confirmed the accuracy and reproducibility of the proposed methods which were carried out by following ICH guidelines. The proposed methods were applied successfully for Simultaneous Determination of Clopidogrel and Aspirin in Combined Tablet formulations.
Cite this article:
Arun B. Kale, Prachyasuman Mohanty, Vishnu P. Choudhari, Abhijit S. Sutar,Swati C. Jagdale, Bhanudas S. Kuchekar. Spectrophotometric Simultaneous Determination of Clopidogrel and Aspirin in Combined Tablet Dosage Form by Ratio Derivative and Area Under Curve Method. Research J. Pharm. and Tech. 4 (1): January 2011; Page 105-108.
Arun B. Kale, Prachyasuman Mohanty, Vishnu P. Choudhari, Abhijit S. Sutar,Swati C. Jagdale, Bhanudas S. Kuchekar. Spectrophotometric Simultaneous Determination of Clopidogrel and Aspirin in Combined Tablet Dosage Form by Ratio Derivative and Area Under Curve Method. Research J. Pharm. and Tech. 4 (1): January 2011; Page 105-108. Available on: https://rjptonline.org/AbstractView.aspx?PID=2011-4-1-32
Pharmacopoeia. Indian Pharmacopoeia Commission. Ghaziabad: 2007; 2: 745-746.
2) The United States
Pharmacopoeia 29, The National Formulary 24, The Official Compendia of
Standards, Asian Edition, 2006; 1582, 1992.
Pharmacopoeia, London: The stationary office, 2004; 1:48,901,902.
4) The Merck Index –
An Encyclopaedia of chemicals, Drugs, and biological, 13th edition,
Merck Research Laboratories, Whitehouse station. New Jersey: 2001; 856, 2421.
5) Mishra P, Dolly
Archana, Simultaneous Determination of Clopidogrel and Aspirin in
pharmaceutical dosage forms, Indian Journal of Pharmaceutical Sciences, 2006;
6) Sinha Purushotam K, Damle Mrinalini C. and Bothara K.G , A Validated
Stability Indicating HPTLC Method for Determination of Aspirin and Clopidogrel
Bisulphate in Combined Dosage Form Eurasian J. Anal. Chem.
2009; 4(2): 152-160.
Rajput S. J, George R. K, and Ruikar Deepti B,
Chemometric Simultaneous Estimation of Clopidogrel Bisulphate and Aspirin from
Combined Dosage Form, Indian Journal of Pharmaceutical Sciences, Indian J Pharm Sci. 2008;Jul–Aug
Tomoko, Nakashima Mihoko, Wada Mitsuhiro, Nakashima Kenichiro
(Nagasaki Univ.) Semi-micro column HPLC-UV determination of clopidogrel
carboxylic acid, aspirin and salicylic acid in rat plasma, Chromatography, Journal Code:L1501A,
9) K Anandakumar, T
Ayyappan, V Raghu Raman, T Vetrichelvan, A.S.K Sankar, D Nagavalli, RP-HPLC
analysis of aspirin and clopidogrel bisulphate in combination, Indian Journal
of Pharmaceutical Sciences, 2007; 69:597-599.
Bahrami, Bahareh Mohammadi and Sajjad Sisakhtnezhad,
High-Performance Liquid Chromatographic determination of inactive carboxylic
acid metabolite of clopidogrel in human serum: Application to a bioequivalence
of Chromatography B 2008;864(1-2):168-172.
11) Zenon Kokot, Kinga
Burda, Simultaneous determination of Salicylic acid and Acetylsalicylic acid in
Aspirin delayed release tablet formulation by second derivative UV
spectrophotometry, Journal of Pharmaceutical and Biomedical Analysis, 1998;
12) Patel G.F,Vekariya
N.R, Dholakiya R.B, Estimation of Aspirin and Atorvastatin calcium in combine
dosage form using Derivative Spectrophotometric method, International Journal
of Pharmaceutical Research, 2010; 2:62-65.
13) Nikelly J.G, Gas
Chromatographic Determination of Acetylsalicylic Acid, Analytical Chemistry, 1964;
14) Mohammad Mainul
Karim, Chi Wan Jeon, Hyuk Sook Lee, Seikh Mafiz Alam, et al Simultaneous
Determination of Acetylsalicylic Acid and Caffeine in pharmaceutical
formulation by first order derivative synchronus flurometric method, Journal of
Fluorescence, 2006; 16:713-721.
15) ICH (2002) ICH
Guidance on analytical method validation. In: Proceedings of the international
convention on quality for the pharmaceutical industry, Toronto, Canada,
16) Beckett A.H, Stenlake J.B, Practical pharmaceutical chemistry, 4th
edition, part 2. CBS Publishers and Distributors; Delhi, 2001; 284, 285, 296.