Page 47 - 2022

Ph.D.
(Pharmacy)
SPECTROPHOTOMETRIC AND CHROMATOGRAPHIC METHOD
DEVELOPMENT AND VALIDATION FOR DETERMINATION OF SOME
ANTIHYPERTENSIVE DRUGS IN THEIR COMBINED DOSAGE FORM
Ph.D. Scholar : Madhuri Pandurang Rode
Research Supervisor : Dr. Dipti B. Patel

Regi. No.: 16146021008
Abstract :
Hypertension is the most common disorder, affecting 1.13 billion individuals globally.
Antihypertensive formulations are considered to be more effective for the management
of hypertension. In recent days, different formulations are available which are used for the
management of hypertension in single and combined dosage forms. So, the present
investigation was undertaken with a view to developing different analytical methods for
simultaneous estimation of antihypertensive drugs in formulations so that we can
measure them in a very precise manner. Three new combinations of antihypertensive
drugs were used for the research work Hydrochlorothiazide and Methyldopa, Torsemide
and Eplerenone and Amlodipine Besylate and Candesartan Cilexetil. The Most sensitive
RP-HPLC method by applying the QbD concept was developed. HPTLC Method was
developed by using fewer amounts of solvents and with good resolution of peaks which
is very helpful for the early phase of formulation development. Chemometric Methods
(CLS and ILS) were developed which are capable to determine constituents in presence of
a matrix very accurately. UV spectrophotometric Methods (Q- Absorbance Ratio method
and First order derivative) were developed as they are very much convenient and less
time consuming and also possible for small scale industries. All developed methods were
validated according to ICH guidelines and statistical comparison was done by ONE WAY
ANOVA method. Developed Analytical methods can be widely used in recent era as this is
a prime requirement for dossier submission and commercial acceptability.

Key words: Hydrochlorothiazide, Methyldopa, Torsemide, Eplerenone, Amlodipine
Besylate, Candesartan Cilexetil, Spectroscopy method, Chemometric method, HPLC, QbD,
HPTLC, Validation, ICH guidelines.

16