RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM, LOSARTAN POTASSIUM, ATENOLOL, AND ASPIRIN FROM TABLET DOSAGE FORM AND PLASMA

Abstract

A rapid, simple, sensitive, and selective chromatographic method has been developed for the simultaneous estimation of atorvastatin calcium, losartan potassium, atenolol, and aspirin in marketed formulation. The separation was carried out on a KYA TECH HiQ Sil C18HS (250 × 4.6 mm i.d., 5 µm particle size) column using a mobile phase of acetonitrile: 0.02 M potassium dihydrogen phosphate buffer (pH 3.4) (70:30% v/v). The chromatographic analysis has been carried out using flow rate of 1 mL/min and detection at 236 nm. The proposed method was applied for analysis of ATN, ASP, LOS and ATO from plasma. ATO showed a linear response in the concentration range of 4–24 µg/mL, LOS and ATN showed a linear response in the concentration range of 20–120 µg/mL and ASP showed a linear response in the concentration range of 30–180 µg/mL in tablet formulation analysis. ATO, LOS, ASP, and ATN showed a linear response in the concentration range of 25–150, 50–300, 100–600, and 50–300 ng/mL in plasma analysis, respectively. The proposed methods for analysis of the four drugs from marketed formulation and plasma have been validated as per ICH and USFDA guidelines, respectively. Thus, proposed methods have their applications in field of bioequivalence and pharmacokinetic studies.

Keywords:

• aspirin
• atenolol
• atorvastatin calcium
• losartan potassium
• plasma
• RP-HPLC

ACKNOWLEDGMENT

The authors are thankful to the Principal, Bharati Vidyapeeth College of Pharmacy, Kolhapur, for providing necessary facilities for research and to CIPLA PVT. LTD., India for providing the gift sample of drugs.

Notes

^a Average of Three Determinations; ^b Standard Deviation.

^a Average of Five Determinations; ^b Standard Deviation; ^c Average of Four Determinations.

^a Relative Standard Deviation (n = 6).

C = Concentration in µg/mL; Y = Unit of Response Factor.

^a Standard Error.

^a Optimized Parameter for Developed Method; ^b Mean of Three Readings; ^c Standard Deviation.

T ˭ Time; D ˭ Day.

^a Average of Fifteen Determinations (calculated at three levels 3 × 5); ^b Standard Deviation.

C = Concentration in µg/mL; Y = Unit of Response Factor.

^a Standard Error.