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Vol. 8, Issue 7 (2019)

Method development and validation of Prevpac combination therapy drugs in spiked human plasma, Deplin and Spasmonal in pharmaceutical dosage forms by Rp-hplc methods

Author(s):
R Vijayalakshmi, VSH Naveena, K Rajasekhar and A Aishwarya Maithili
Abstract:
The intention of the present work is to develop simple, precise and accurate RP-HPLC methods for the estimation of Prevpac combination therapy drugs (30 mg capsules of lansoprazole; LAN, 500 mg capsules of amoxicillin; AMX and 500 mg tablets of clarithromycin; CLM) in spiked human plasma, Method A; Deplin tablets (15 mg levomefolate calcium; LMF) in pharmaceutical formulation, Method B and Spasmonal (60 mg capsules of alverine citrate; ALV) in marketed formulation, Method C. Prevpac combination therapy is employed to treat ulcer effectively, since the dosages being given separately, there is need to study the protein binding of these drugs in plasma to estimate their absorbance in plasma. The effective chromatographic separation was accomplished on phenomenex C18 (250 x 4.6 mm, 5 µm particle size) column for all the methods. The methods were optimized by isocratic elution of mobile phase constituting Acetonitrile and phosphate buffer (pH 6) in the ratio of 70:30 set at a flow rate of 0.6 mL/min monitored at 227 nm for Method A, methanol : acetate buffer (pH4.4) in a ratio of 80:20 %v/v and studied at 290 nm, Acetonitrile: Buffer pH (5) in the ratio of 80:20, %v/v for method B and Acetonitrile: Buffer pH (5) in the ratio of 80:20, %v/v and monitored at 215 nm for Method C, respectively. The liquid chromatography methods were extensively validated and all the parameters were within the acceptance criteria with correlation of 0.999, retention time less than 6 min and percentage RSD less than 2 for all the three methods. The methods were proved to be more accurate, simple, precise and rapid by statistical validation, recovery studies.
Pages: 61-67  |  847 Views  126 Downloads


The Pharma Innovation Journal
How to cite this article:
R Vijayalakshmi, VSH Naveena, K Rajasekhar, A Aishwarya Maithili. Method development and validation of Prevpac combination therapy drugs in spiked human plasma, Deplin and Spasmonal in pharmaceutical dosage forms by Rp-hplc methods. Pharma Innovation 2019;8(7):61-67.

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