Valosartan Case Study

INTRODUCTION: [1]

Valsartan is an Angiotensin II Receptor Antagonist (commonly called an ARB, or angiotensin receptor blocker), that is selective for the type I (AT1) angiotensin receptor. It is used to treat high blood pressure, congestive heart failure, and to reduce death for people with left ventricular dysfunction after having had a heart attack. Figure 1: Valsartan

Nifedipine is a dihydropyridine calcium channel blocker that primarily blocks L-type calcium channels. Its main uses are as an antianginal and antihypertensive, although a large number of other indications have recently been found for this agent, such as Raynaud's phenomenon, premature labour, and painful spasms of the esophagus such as in cancer and tetanus patients.

No. Parameters VALSARTAN NIFEDIPINE

1 Linearity Range (μg/ml) 4-20 1.5-7.5

2 Regression Line Equation

(y = mx + c) y = 39992x+68009 y = 11484x-18115

3 Correlation Coefficient (R²) 0.999 0.998

4 Intraday Precision (%RSD, n=3) 0.3584 – 0.5033 0.2983 – 0.4804

5 Interday Precision (% RSD, n=3) 0.4214 – 0.6017 0.4378 – 0.5492

6 Repeatability (% RSD, n=6) 0.5635 0.4628

7 LOD (μg/ml) 0.1067 0.2078

8 LOQ (μg/ml) 0.3236 0.6298

9 % Recovery Study (n=3) 99.50 – 100.15 99.33 – 100.40

REFERENCES:

1. Indian Pharmacopeia 2010, Ghaziabad: Govt. of India Ministry of Health and

Family Welfare, The Controller of Publication Indian Pharmacopoeia Commission, 2010 vol- 1, 3, pp 382, 456, 1779-1780, 2287.

2. JB Park, JW Ha, HO Jung and MY Rhee, “Randomized Trial comparing the effects of a low-dose combination of Nifedipine GITS and Valsartan versus High dose Monotherapy on Central Hemodynamic in patient with inadequately controlled Hypertension: FOCUS Study” NCBI. 2014, 19(5), 294-301.

3. ICH, Q2 (R1), 2005, Validation of Analytical Procedure: Text and Methodology, International Conference on Harmonization, IFPMA, Geneva,