An innovative FT-IR method that is accurate, uncomplicated and cost-effective has developed for the simultaneous estimation of atorvastatin calcium and clopidogrel bisulphate in combined dose form. The wave number that was selected for atorvastatin calcium was 3417 cm^-1, which fell within the range of 3450-3400 cm^-1 (hydroxide), and the wave number that was selected for clopidogrel bisulphate was 1749 cm^-1, which fell within the range of 1760-1745 cm^-1 (carboxylic). The linearity range followed was in concentration ranges of 1.0-2.5% w/w for ATR (atorvastatin calcium) and 7.5-20% w/w for CLP (clopidogrel bisulphate), respectively. Both drugs' percentage relative standard deviations (%R.S.D.) came in below 2, suggesting that they meet the criteria set forth by the ICH for accuracy and precision. The only experiments that were carried out regarding the stability of the solid state were photolysis, thermal, and sunlight degradation. The method that was described can be used for the simultaneous estimation of clopidogrel bisulphate and atorvastatin calcium in pharmaceutical dosage form, and the % assays ranges observed for clopidogrel bisulphate were 99.32% and that for atorvastatin calcium were 99.55%.

      [1]      O. W. Foye, “Principles of medicinal chemistry,” 4th edition, B.T. Waverly Pvt. Ltd, New Delhi, pp. 415, 2007.

      [2]      S. Tetik.; Ak Koray.;S Isbir.; E Eksioglu-Demiralp.;S Arsan.;O Iqbal.;T Yardimci.;

Clin Appl Thromb Hemost ,April 201016 , 2 , pp189-198.

      [3]      “ICH Tripartite Guideline, Q2R1, Validation of Analytical Procedure: Text and Methodology,” 2005.

      [4]         S.C. Dangre; Development of RP-Hplc method for simultaneous estimation of atorvastatin calcium & clopidogrel bisulphate in pharmaceutical capsule dosage form, the journal pharmacy technology, 2012; 641-644.

      [5]         S. D. Raut; Development of RP-Hplc method for simultaneous estimation of atorvastatin calcium & clopidogrel bisulphate in their pharmaceutical preparation, journal of pharmacy research,2011; 2307.

      [6]         M .Neeharika; RP-hplc method development for simultaneous estimation of clopidogrel bisulphate & atorvastatin calcium in capsule dosage form, IAJ of pharmaceutical research, 2014.

      [7]         M. D. game; Quantitative analysis for clopidogrel bisulphate and aspirin by second derivate spectrometric method in pharmaceutical preparation, IJ of chem.Tech research,2010; 1886-1891.

      [8]         S. S. panda; had performed had performed ion pairing RP-hplc method for simultaneous determination of aspirin & clopidogrel bisulphate in Tablet & capsule dosage form, IJ of pharma tech research, 2010; 269-273.

      [9]         H.O.kaila;A simple & rapid utra-performance liquid chromatographic assay method for the simultaneous determination of aspirin, clopidogrel bisulphate & atorvastatin calcium in capsule dosage form, IJ of chem.tech research, 2011; 456-465.

     [10]       B.M.gurupadayya; Bio-analytical determination of clopidogrel & pantoprazole by RP-hplc method in rat plasma: application to drug interaction study, asian journal of pharmaceutical research, 2014.

     [11]       M. vanita sri;Simultaneous determination of aspirin, clopidogrel bisulphate & atorvastatin calcium in capsule form by RP-hplc, 2010.

     [12]       S. sherikar & P. Mehta ; Comprehensive assessment of degradation behaviour of aspirin and atorvastatin singly and in combination by using a validated RP- hplc method, 2012.

       [13]     P.K. shrivastava; Concurrent estimation of clopidogrel bisulphate and aspirin in tablets by validated RP-hplc method, scientia pharmaceutica, 2013; 73.

       [14]     S.V.londhe; Development & validation of a reversed-phase HPLC method for simultaneous determination of aspirin, atorvastatin calcium & clopidogrel bisulphate in capsules, IJ pharmaceutical sciences, 2011.

       [15]     K.anandkumar; RP-hplc analysis of aspirin & clopidogrel bisulphate in combination, IJ of pharmaceutical sciences, 2007; 597-599.

[18] P.A. salunke;Simultaneous estimation of amlodipine & clopidogrel in bulk & marketed formulation by Q-absorbance ratio method, Indo American journal of pharmaceutical research, vol.4-2014.

[19]  ICH, Stability Testing of New Drug Substances and Products Q1A(R2), International Conference on Harmonisation, IFPMA, Geneva, 2003.

[20] FDA, Guidance for Industry: Stability Testing of Drug Substances and Drug Products (Draft Guidance), Food and Drug Administration, Rockville, MD, 1998.

Please cite this article in press as Anitha K et al. FT-IR Spectrophotometric Method for Simultaneous Estimation of Atorvastatin calcium and Clopidogrel bisulphatein Combined Dosage Form. Indo American Journal of Pharmaceutical Research.2020:10(12)