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The document presents a study on the simultaneous estimation of Enalapril Maleate and Losartan Potassium in tablet dosage form using RP-HPLC. It outlines the methodology, including the selection of chromatographic conditions, method validation, and a literature review of previous studies. The aim is to develop a simple, precise, and cost-effective analytical method following ICH guidelines.

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14 views15 pages

Major PRC 1

The document presents a study on the simultaneous estimation of Enalapril Maleate and Losartan Potassium in tablet dosage form using RP-HPLC. It outlines the methodology, including the selection of chromatographic conditions, method validation, and a literature review of previous studies. The aim is to develop a simple, precise, and cost-effective analytical method following ICH guidelines.

Uploaded by

nalapatlanimithagoud3
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SIMULTANEOUS ESTIMATION OF ENALAPRIL

MALEATE AND LOSARTAN POTASSIUM IN


TABLET DOSAGE FORM BY USING RP-HPLC

Presented by
N.DIVYA
(21T21S1206)
Under the guidance of
Dr. A. RAJA REDDYM.Pharm.,Ph.D
Associate Professor
DEPARTMENT OF PHARMACEUTICAL ANALYSIS
CMR COLLEGE OF PHARMACY
CONTENTS
 Introduction
 Literature review
 Aim & objective
 Drug profile
 Plan of work
 Bibilography
INTRODUCTION
CHROMATOGRAPHY
• Chromatography is a method in which separation of components takes place between stationary phases and a mobile
phase.

HPLC - High Performance Liquid Chromatography


• It is a type of liquid chromatography where the sample is forced through column that is packed with a stationary phase
composed of irregularly or spherical shape particles or a porous membrane by a liquid (mobile phase) at high pressure.

• The main principle of separation is adsorption as well as partition chromatography is depending on the nature of
stationary phase. If stationary phase is solid principle is based on adsorption and if the stationary phase is liquid
principle is based on partition chromatography.
TYPES OF HPLC
• Normal phase chromatography:-Stationary phase is polar and Mobile phase is non polar.
• Reverse phase chromatography:-Mobile phase is polar and Stationary phase is non polar. 1
INSTRUMENTATION
RP-HPLC METHOD DEVELOPMENT
Selection of the HPLC method and conditions

Establish sample preparation procedure

Selection of initial conditions(modes of seperation,column)

Mobile phase selection

Selectivity & system optimization

Method validation
VALIDATION OF ANALYTICAL
METHOD
LITERATURE
Author Title
REVIEW
Chromatographic conditions Results Journal details
name
Bhaumik Method Development Mobile phase:- Enalapril Maleate Indo American
C Patel and Validation for Buffer:Acetonitrile LOQ-0.365 µg/ml Journal of
Simultaneous (60:40 v/v) pH4.5 adjusted LOD- 0.120 Pharmaceutical
Estimation of Enalapril With o-Phosphoric Acid %RSD-98.47% - Research2
Maleate and Losartan Stationary phase:-C-18 BDS 100.68%
Potassium in Bulk and Hypersil column (250mm × Losartan Potassium
Pharmaceutical Dosage 4.6 mm id 5µm) LOQ-1.839 µg/ml
Form λmax- 235nm LOD- 0.606
flow rate-1ml/min %RSD-98.49% -
100.61%

Priyanka RP- HPLC Method for Mobile phase:-0.02% Losartan potassium International
R. Patil, Simultaneous triethylamine in water: Retention time-2.32 Journal of
Sachin U. Estimation of Losartan acetonitrile (60:40) %RSD-0.74 ChemTech
Rakesh, P. potassium & Stationary phase:-RP C-18 Amolodipine besylate Research,ISSN:0
N.Dhabale Amlodipine besylate in Column (Microsorb-MV 100- R.T-10.10 min, 974-42903
K. B. Tablet Formulation 5, 250 x 4.6 mm) %RSD-0.67
Burade. λmax- 226 nm,
Flow rate :- 1ml/min
Author name Title Chromatographic condition Results Journal details

Vishwa m. Rp-HPLC method for Mobile phase:-phosphate Enalapril maleate International journal
dave1, dr. simultaneous buffer: acetonitrile: Retention time-7.749 of pharma sciences
dilip g. estimation of enalapril methanol (65:25:10 v/v/v) LOD - 0.058 and research,ISSN:
maheshwar maleate and Stationary phase:-hypersil Chlorthalidone 0975-94924
chlorthalidone in bds C18 (250 x 4.6mm, 5 Retention time-4.247
synthetic mixture μm ) LOD-0.047
λmax- 210nm Recovery studies 99.83
Flow rate:-1ml/min

K.Srinivasa Rp-HPLC method for Mobile phase:- Losartan potassium Indian journal of
rao the determination of acetonitrile:methanol:10mm LOD-0.071 pharmaceutical
losartan potassium tetra butyl ammonium LOQ-0.11 science5
and ramipril in hydrogen sulphate in water Retention time-4.7
combined dosage (30:30:40% v/v/v ) Ramipril
form Stationary phase:- hypersil LOD-0.215
ods C18, 4.6×250 mm, 5 LOQ-0.332
μm column Retention time-3.3 min
λmax- 210 nm
AIM & OBJECTIVE
AIM
• To develop a new RP- HPLC method for the simultaneous estimation of Enalapril maleate and
Losartan potassium in tablet dosage form.

OBJECTIVE
• It`s main objective is to develop a simple, precise,cost effective and validated method for
Enalapril maleate and Losartan potassium following ICH guidelines which includes the
validation parameters and report it within the limits.
DRUG PROFILE
PARAMETERS DETAILS
DRUG: Enalapril Malaete
IUPAC NAME: (2S)-1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl)
3phenylpropyl] amino] propanoyl] pyrrolidin-2-
carboxylic acid hydrogen maleate
MOLECULAR FORMULA : C20H28N2O5
MOLECULAR WEIGHT 492.5
SOLUBILITY: Freely soluble in methanol, sparingly soluble in
water, insoluble in methylene chloride.
APPEARANCE: Solid
LOG P 0.07
pKa 2.92
DOSE 2.5 mg, 5 mg, 10 mg, and 20 mg
PARAMETERS DETAILS

DRUG: Losartan potassium

IUPAC NAME: 4-butyl-4-chloro-1- [[2′-(1H-tetrazol-5-yl)[1,1′-


biphenyl]- 4- yl]methyl]-1H-imidazole-5-
methanol.
MOLECULAR FORMULA : CH22ClKN6O

MOLECULAR WEIGHT 461.0

SOLUBILITY: Freely soluble in water, slightly soluble in


acetonitrile, soluble in isopropyl alcohol.
APPEARANCE: Solid

LOG P 1.19

pKa 5.5

DOSE 25 mg, 50 mg, 100 mg6


MECHANISM OF ENALAPRIL & LOSARTAN
PLAN OF WORK
Literature Selection of
Solubility
review drug

Method Determine the


Optimization development absorption
maxima

Analytical
method
validation
BIBILOGRAPHY

1. B.K Sharma,Instrumental and Chemical analysis,Goel publications,Edition 2,2004 pg:-240-290.


2. Bhaumik c patel,Method development and validation for simultaneous estimation of Enalapril maleate and Losartan
potassium in bulk and pharmaceutical dosage form, indo american journal of pharmaceutical research,2013.
3. Priyanka r. patil, sachin u. rakesh,p. n. dhabale, k.b.burade,RP-HPLC method for simultaneous estimation of losartan
potassium and amlodipine besylate in tablet formulation, international journal of chemtech research, ISSN : 0974-
4290,2009.
4. Vishwa.dave,dr. dilip g. maheshwari,RP-HPLC method for simultaneous estimation of enalapril maleate and
chlorthalidone in synthetic mixture, international journal of pharma sciences and research, ISSN : 0975-9492,2015.
5. K.Srinivasa rao, RP-HPLC method for the determination of losartan potassium and ramipril in combined dosage
form,Indian journal of pharmaceutical science.
6. National center for biotechnology information (2022). pubchem compound summary for cid 5388962, enalapril
retrieved november18,2022 fromhttps://pubchem.ncbi.nlm.nih.gov/compound/enalapril .

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