Simultaneous HPTLC analysis of aspirin, atorvastatin calcium and clopidogrel bisulphate in the bulk drug and in capsules

• Autorzy: Londhe S. V , Mulgund S. V , Deshmukh R. S , Jain K. S
• Języki publikacji: EN

Abstrakty

EN

A simple, precise, and accurate HPTLC method has been established for simultaneous quantification of aspirin, atorvastatin calcium and clopidogrel bisulphate in the bulk drug and in a capsule dosage form. Chromatographic separation of the drugs was performed on aluminium foil plates precoated with silica gel 60 F 254 , with toluene-methanol-formic acid 6.5:3.5:0.1 ( v / v ) as mobile phase. Densitometric evaluation of the separated zones was performed at 254 nm. The three drugs were satisfactorily resolved with R F ± SD values 0.26 ± 0.01, 0.47 ± 0.01, and 0.78 ± 0.01 for aspirin, atorvastatin calcium, and clopidogrel bisulphate, respectively. The method was validated for linearity, specificity, accuracy, precision, and robustness, in accordance with ICH guidelines. Results from recovery studies indicated acceptable recovery of the drugs from the capsule dosage form. The intra-day and inter-day relative standard deviations were in the ranges 0.17–0.73% and 0.46–1.03% for aspirin, 0.36–0.87% and 0.44–0.62% for atorvastatin calcium, and 0.25–0.69% and 0.35–0.94% for clopidogrel bisulphate. The method proved to be a rapid and cost-effective quality-control tool for routine simultaneous analysis of aspirin, atorvastatin calcium, and clopidogrel bisulphate in the bulk drug and in a capsule formulation.

Słowa kluczowe

EN

HPTLC; aspirin; atorvastatin calcium; clopidogrel bisulphate

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2010
• Tom: Vol. 22, no. 2
• Strony: 297--305
• Opis fizyczny: Bibliogr. 26 poz., rys., tab.

Twórcy

autor

Londhe S. V

• Sinhgad College of Pharmacy Department of Pharmaceutical Chemistry Vadgaon, Pune 411041 India

autor

Mulgund S. V

• Sinhgad College of Pharmacy Department of Pharmaceutical Chemistry Vadgaon, Pune 411041 India

autor

Deshmukh R. S

• Sinhgad College of Pharmacy Department of Pharmaceutical Chemistry Vadgaon, Pune 411041 India

autor

Jain K. S

• Sinhgad College of Pharmacy Department of Pharmaceutical Chemistry Vadgaon, Pune 411041 India

Bibliografia

• [1] S. Saraf, S. Saraf, and G. Garg, Indian J. Pharm. Educ. Res., 42 , 74–77 (2008)
• [2] G. Luo, Q. Lan, Z. Wang, and G. Zhou, Yao Xue Xue Bao., 24 , 684–689 (1989)
• [3] United State Pharmacopoeia — National Formulary, The Official Compendia of Standards, Webcom Limited Toronto, Ontario, 180, 2005
• [4] British Pharmacopoeia, published by the stationary office, London, 1 , pp. 184–185, 2007
• [5] Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission, Ghaziabad, 2 , pp. 745–746, 2007
• [6] Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, The Indian Pharmacopoeia Commission, Ghaziabad, 2 , pp. 749–750, 2007
• [7] S. Dhaneshwar, S. Dhaneshwar, P. Deshpande, and M. Patil, Acta Chromatogr., 19 , 141–148 (2007)
• [8] Y. Gomez, E. Adams, and J. Hoogmartens, J. Pharm. Biomed. Anal., 34 , 341–348 (2004)
• [9] United States Pharmacopoeia — National Formulary, The Official Compendia of Standards, Webcom, Toronto, Ontario, pp. 516–517, 2005
• [10] A. Mitakos and I. Panderi, J. Pharm. Biomed. Anal., 28 , 431–438 (2002)
• [11] R. Pirola, S. Bareggi, and G. De Benedittis, J. Chromatogr. B, 705 , 309–315 (1998)
• [12] M. Gandhimathi, T. Ravi, A. Abraham, and R. Thomas, J. Pharm. Biomed. Anal., 32 , 1145–1148 (2003)
• [13] G. McMahon, S. O’Connor, D. Fitzgerald, S. Roy, and M. Kelly, J. Chromatogr. B, 707 , 322–327 (1998)
• [14] J. Franeta, D. Agbaba, S. Eric, S. Pavkov, S. Vladimirov, and M. Aleksic, J. Pharm. Biomed. Anal., 24 , 1169–1173 (2001)
• [15] S. Erturk, E. Sevinc, L. Erosy, and S. Ficicioglu, J. Pharm. Biomed. Anal., 33 , 1017 (2003)
• [16] K. Manoj, P. Shanmugapandiyan, and S. Anbazhagan, Indian Drugs, 41 , 284 (2004)
• [17] K. Rajeswari, G. Sankar, and J. Seshagirirao, Indian J. Pharm. Sci., 68 , 275 (2006)
• [18] F. Havaldar and V. Chaudhari, Asian J. Chem., 17 , 2502 (2006)
• [19] S. Yadav, D. Mhaske, A. Kakad, and S. Dhaneshwar, Indian J. Pharm. Sci., 67 , 182 (2005)
• [20] K. Anandakumar, T. Ayyappan, V. Raman, T. Vetrichelvan, A. Sankar, and D. Nagavalli, Indian J. Pharm. Sci., 69 , 597–599 (2007)
• [21] J. Sippel, JAOAC Int., 91 , 67–72 (2008)
• [22] H. Agrawal, Talanta, 61 , 581–589 (2003)
• [23] R. Patel, M. Shankar, M. Patel, and K. Bhatt, J. AOAC Int., 91 , 750–755 (2008)
• [24] ICH Guidance on Analytical Method Validation. In: Proc. Int. Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September, 2002
• [25] ICH, Q2A Validation of Analytical Procedures: Methodology International Conference on Harmonization, Geneva, October, 1994
• [26] ICH, Q2B Validation of Analytical Procedures: Methodology International Conference on Harmonization, Geneva, March, 1996