Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastatin and Nicotinic Acid from Their Combined Dosage Form
 
More details
Hide details
1
Department of Pharmaceutical Chemistry, S. K. Bhoyar College of Pharmacy, New Kamptee, Nagpur- 441002 (M.S.), India
CORRESPONDING AUTHOR
Krishna R. Gupta   

Department of Pharmaceutical Chemistry, S. K. Bhoyar College of Pharmacy, New Kamptee, Nagpur- 441002 (M.S.), India
Publish date: 2017-10-07
 
Eurasian J Anal Chem 2009;4(3):294–303
KEYWORDS
ABSTRACT
The study describes development and subsequent validation of a stability indicating reverse-phase HPLC method for simultaneous estimation of atorvastatin (ATR) and nicotinic acid (NTA) from their combined dosage form. The proposed RP-HPLC method utilizes a Phenomenex® C18, 5µm, 250mm X 4.6mm i.d. column, at ambient temperature, optimum mobile phase consisted of acetonitrile and 50mM potassium dihydrogen phosphate buffer (68:32, v/v), apparent pH adjusted to 4.5±0.1 with phosphoric acid solution, effluent flow rate monitored at 0.8 ml/min, and UV detection at 247 nm. The combination drug product are exposed to thermal, acid/base hydrolytic, humidity and oxidative stress conditions, and the stressed samples were analyzed by proposed method. The described method is linear over the range of 2—10µg/ml and 20—100µg/ml for ATR and NTA, respectively. The mean recoveries are 100.99 and 102.65% for ATR and NTA, respectively. The intermediate precision data obtained under different experimental setup, the calculated value of coefficient of variation (CV,%) is found to be less than critical value. The limit of detection for ATR and NTA are found to be 0.16 and 0.12 µg/ml, respectively. Chromatographic peak purity data of ATR and NTA indicated no co-eluting peaks with the main peaks of drugs which demonstrated the specificity of assay method for their estimation in presence of degradation products. The proposed method can be useful in the quality control of combination drug products.
 
REFERENCES (31)
1.
J. L. Witzum (1996) Drugs Used in the Treatment of Hyperlipoproteinemias, 9th ed., J. G. Hardman, L. E. Limbird and P. B. Molonoff, Eds. McGraw-Hill, NY: 875-897.
 
2.
P. Walsh (2000) Physician Desk Reference 5th ed., Medical Economics Company Inc., Montvale, NJ: 2358-2360.
 
3.
S. Budavari (2001) The Merck Index- An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th ed., Merck & Co. Inc., Whitehouse Station, NJ: 148.
 
4.
S. Budavari (2001) The Merck Index- An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th ed., Merck & Co. Inc., Whitehouse Station, NJ : 86-87.
 
5.
ICH, Q1A Stability Testing of New Drug Substances and Products, in: Proceeding of the International Conference on Harmonization, Geneva, October 1993.
 
6.
The United States Pharmacopoeia (2003), 26th ed., US Pharmacopoeial Convention, Rockville, MD, p. 1151.
 
7.
British Pharmacopoeia (2004) Controller of Her Majesty’s Stationary Office, Norwish, Vol II, 1373.
 
8.
Sankar D G, Raju M S M, Sumanth K, Latha P V M (2005) HPLC method for estimation of Atorvastatin in pure and pharmaceutical dosage form. Asian J Chem 17: 2571-2574.
 
9.
Erturk S, Sevinc A E, Ersoy L, Ficicioglu S (2003) HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. J Pharm Biomed Anal 33: 1017-1023.
 
10.
Puratchikody A, Valarmathy R, Shiju P J (2003) Rukumani K. RP-HPLC determination of atorvastatin calcium in solid dosage forms. Pharm Rev 1:79-80.
 
11.
Stanisz B, Kania L (2006) Validation of HPLC method for determination of atorvastatin in tablets and for monitoring in solid phase. Acta Pol Pharm 63: 471-476.
 
12.
Bahrami G, Mohammadi B, Mirzaeei S, Kiani A (2005) Determination of atorvastatin in human serum by reverse phase high performance liquid chromatography with UVdetection. J Chromatogr B: Analyt Technol Biomed Life Sci 826: 41-45.
 
13.
Jemal M, Ouyang Z, Chen B C, Teitz D (1999) Quantitation of atorvastatin and its bio-transformation products in human serum by HPLC with electro spray tandem mass spectrometry. Rapid Commun Mass Spectrom 13: 1003-1015.
 
14.
Hermann M, Christensen H, Reubsaet J L (2005) Determination of atorvastatin and metabolites in human plasma with solid phase extraction followed by LC-tandem MS. Anal Bioanal Chem 382: 1242-1249.
 
15.
Guiphen E, Sisk G D, Scully N M, Glennon J D (2006) Rapid analysis of atorvastatin calcium using capillary electrophoresis and microchip electrophoresis. Electrophoresis 27: 2338-47.
 
16.
Dhaneshwar S R, Yadav S, Mhaske A, Kadam S (2005) HPTLC method for determination of content uniformity of atorvastatin calcium tablets. Indian J Pharm Sci 67: 182-186.
 
17.
Illarionova E A, Syrovatskii I P, Abramova L V (2002) Spectrophotometric determination of nicotinic acid. Zavodskaya Laboratoriya 68: 9-12.
 
18.
Tsuruta Y, Kohashi K, Ishida S, Ohkura Y (1984) Determination of nicotinic acid in serum by high performance liquid chromatography with fluorescence detection. J Chromatogr 30: 309-15.
 
19.
Hsieh Y, Chen J (2005) Simultaneous determination of nicotinic acid and its metabolites using hydrophilic interaction chromatography with tandem mass spectrometry. Rapid Commun Mass Spectrom 19: 3031-3036.
 
20.
Minamisawa M, Yoshida S, Takai N (2004) Determination of biologically active substances in roasted coffees using a diode array HPLC system. Anal Sci 20: 325-328.
 
21.
Tokunaga H, Okada S, Kimura T (1989) Determination of nicotinic acid in injections by high performance liquid chromatography. Eisei Shikenjo Hokoku 107: 108-112.
 
22.
Gandhimathi M, Ravi T K, Varghese A, Ninan A (2003) RP-HPLC method for determination of simvastatin and nicotinic acid in tablets. Indian Drugs 40: 707-710.
 
23.
Chatzimichalakis P F, Samanidou V F, Verpoorte R, Papadovannis J N (2004) Development of a validated HPLC method for the determination of B-complex vitamins in pharmaceuticals and biological fluids after solid phase extraction. J Sep Sci 27: 1181-1188.
 
24.
Li K (2002) Simultaneous determination of nicotinamide, pyridoxine hydrochloride, thiamine mononitrate and riboflavin in multivitamin with minerals tablets by reversephase ion pair high performance liquid chromatography. Biomed Chromatogr 16: 504- 507.
 
25.
Zarzycki P K, Kawalski P, Nowakowska J, Lamparczyk H (1995) High performance liquid chromatographic and capillary electrophoretic determination of free nicotinic acid in human plasma and separation of its metabolites by capillary electrophoresis. J Chomatogr A 709: 203-208.
 
26.
Sankar D G, Raju M S M, Murthy T K, Rajendra J A, Sastry C S P (2003) Determination of atorvastatin and pantoprazole using an analytical reagent 1, 10- phenanthroline. J Inst Chem India 75: 47-48.
 
27.
Freedy H, Chaudhary V (2005) Rp-HPLC determination of atrovastatin calcium and amlodipine besylate from pharmaceutical formulation. Asian J Chem 17: 2502-2508.
 
28.
Manoj K, Shanmugapandiyan P, Anbazhagan S (2005) Rapid HPLC method for simultaneous estimation of atorvastatin and aspirin from capsule formulation. Indian Drugs 41: 284-289.
 
29.
ICH, Q2B Validation of Analytical Procedure: Methodology, in: Proceeding of the International Conference on Harmonization, Geneva, March 1996.
 
30.
ICH, Guidance on Analytical Method Validation, in: Proceedings of International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September 2002.
 
31.
Singh S, Bakshi M (2000) Guidance on conduct of stress tests to determine inherent stability of drugs. Pharm Technol 24: 1-14.
 
eISSN:1306-3057