SIMULTANEOUS ESTIMATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY HPTLC

MRUNALINI H. KULKARNI; POONAM R. INAMDAR; PALLAVI DHEKALE; AMRITA THAKUR; SWATI MUTHA; NEETA RAI; VISHAL GALAVE

doi:10.22159/ijap.2022.v14ti.1

Authors

MRUNALINI H. KULKARNI Department of Pharmacy, School of Pharmacy Vishwakarma University, Pune
POONAM R. INAMDAR Department of Pharmacy, School of Pharmacy Vishwakarma University, Pune
PALLAVI DHEKALE Department of Pharmacy, School of Pharmacy Vishwakarma University, Pune
AMRITA THAKUR Department of Pharmacy, School of Pharmacy Vishwakarma University, Pune
SWATI MUTHA Department of Pharmacy, School of Pharmacy Vishwakarma University, Pune
NEETA RAI Department of Pharmacy, School of Pharmacy Vishwakarma University, Pune
VISHAL GALAVE Navsahyadri Institute of Pharmacy, Pune, India

DOI:

https://doi.org/10.22159/ijap.2022.v14ti.1

Keywords:

Valsartan, Hydrochlorothiazide, HPTLC, Tablet dosage Form, ICH guidelines

Abstract

Objective: The prevalence of Hypertension in India is estimated to be greater than 45% in the middle age population; elevated hypertension is one of the known causes of CHD, strokes and death. The objective of this work was to develop a simple, accurate and robust HPTLC method was developed for simultaneous estimation of Valsartan and Hydrochlorothiazide in bulk and tablets.

Methods: The mobile phase optimized by HPTLC method consists of Toluene: Ethyl acetate: formic acid in the ratio of (3:7:0.3, v/v/v). The solvent front was a run-up to a distance of 80 cm; which took 15 min for the development of TLC plate. Analytical Wavelength for UV detection selected was at 225 nm.

Results: Retention factor was found to be 0.74±0.02 and 0.45±0.02 for VAL and HTZ, respectively. Developed chromatographic method was validated as per ICH, Q2(R1) guidelines. Linearity was found at concentration range 300-1800 ng/spot (r² = 0.999), 50-300ng/spot (r² = 0.9991) for VAL and HTZ respectively. LOD were found to be 23.02 ng/spot and 4.12ng/spot respectively for Valsartan and Hydrochlorothiazide. LOQ was found to be 69.76ng/spot and 12.5ng/spot for, Valsartan and Hydrochlorothiazide respectively.

Conclusion: Percentage RSD was found out to less than 2, indicating the developed method was precise and can be successively applied to pharmaceutical formulation. No interferences with the excipients were reported.

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References

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