Development of High Performance Liquid Chromatographic Estimation of Domperidone and Lansoprazole

 

Pooja Agarwal1, Beena Kumari2, Sangeeta2, Manish Kumar3*

1Department of Pharmaceutical Science, Shivdan Singh Institute of Technology and Management,

Aligarh, Uttar Pradesh.

2Department of Pharmaceutical Science, Indira Gandhi University, Meerpur, Rewari, Haryana, India-123401.

3M.M. College of Pharmacy, Maharishi Markandeshwar (Deemed to be University),

Mullana, Ambala, Haryana, India.

*Corresponding Author E-mail: manish_singh17@rediffmail.com

 

ABSTRACT:

The combination of Domperidone and Lansoprazole is very useful in Gastro-esophageal disinfection (Dyspepsia). These methods provide means to separate the components characterize and quantify the components. An accurate, precise, specific and simple HPLC method was developed for simultaneous estimation of Domperidone and Lansoprazole. By this method retention time, linearity and accuracy data is respectively found for Domperidone and Lansoprazole. Mobile phase was prepared by mixing 51 volume of Acetonitrile  and 49 volume of Ammonium Acetate (51:49 V/V) then 25mg each of Domperidone and Lansoprazole was dissolved in small volume of Acetonitrile: Ammonium Acetate (51:49 V/V) separately. Retention time was recorded 4.330 ± 0.003 minute and 5.820 ± 0.003 minute for Domperidone and Lansoprazole with 1.0 ml/min flow rate. The low value of % R.S.D indicates that this method is precise and accurate. Thus it can be concluded that the proposed method was good approach for obtaining reliable result.

 

KEYWORDS: Domperidone, Lansoprazole, RP-HPLC, Validation method, Method development.

 

 

INTRODUCTION:

Domperidone: The chemical name of Domperidone is 6-chloro-3-[1-[3-(2-oxo-3H-benzoimidazol-1-yl) propyl] piperidin-4-yl]-1H-benzoimidazol-2-one. Domperidone is an anti-dopaminergic drug which is used to stimulated lactation. It is a d2 antagonist, it gives an Antiemetic & Prokinetic actions. Domperidone crosses the blood-brain barrier poorly. Domperidone act on CTZ, Metoclopramide efficacy is higher than antiemetic Domperidone. Bioavailability is only 15% via a first pass metabolism and plasma half life is 7.5 hours. Domperidone suppress nausea and vomiting. Chemical structure of Domperidone is shown in Figure 1.It is used in Parkinson’s disease and effective in treatment of gastro paresis. Domperidone is given in combination with metoclopramide and granisetron in treatment of nausea and vomiting1,2.

 

Lansoprazole:

The chemical name of Lansoprazole is 2-{[3-mthyl-4-2,2,2-trifuroethoxy) pyridin-2-yl] methylsulfinly]-1H-benzimidazole. It is a proton pump inhibitor which prevents the stomach from producing acid. Lansoprazole in netural PH is inactive, but the PH ≤ 5 it forms a two cationic charges i.e. a sulphenic acid and a sulphenamide, which react covalently with H+K+ATPase (with SH groups) and inactivate it irreversibly, especially two molecule of bind with the enzyme. The H†K† ATPase enzyme have a specific location in apical membrane of the parietal cells. Acid secretion is caused by synthesis of H+K+ATPase new molecule. It gets inhibited by gastric mucosal carbonic anhydrates. Lansoprazole is inhibited by the H+K+ATPase by partly reversible. Chemical structure of Lansoprazole is shown in Figure 1. Lansoprazole plasma half life is longer than omeprazole3,4.

 

Figure 1: Chemical structure of Domperidone and Lansoprazole

 

MATERIAL AND METHODS:

HPLC system of Shimadzu –SPD 10A with Phenomenex – Luna 5Ω x 250 x 4.6 mm column was used UV-Visible spectrophotometer of Shimadzu with wavelength detector SPD-10A vp. Analytical weighing balance of Shimadzu (Aux 200) was used for weighing. Sonicator (Sonica 2200 MH) was used with Millipore filteration kit for solvents. Domperidone and Lansoprazole samples were received as a gift sample by micro labs, Banglore.

 

Preparation of Mobile phase:

Mobile phase was prepared by mixing 51 volume of Acetonitrile and 49 volume of Ammonium Acetate in the ratio is 51:49 v/v the mobile phase was sonicated for 10 min. and filtered through 0.45 m nylon membrane filter.

 

Standard Solution of Domperidone and Lansoprazole:

Accurately weighed 25 mg of Domperidone and Lansoprazole in 25 ml of volumetric flask separately and dissolve in small volume of Acetonitrile: Ammonium Acetate up to the mark with same solvent to obtaining each drug of concentration 1000 mg/ml5,6.

 

Chromatographic condition:

Mobile Phase A: Acetonitrile and Mobile phase B: Ammonium Acetate (51:49v/v) wavelength for Domperidone is 200nm and for Lansoprazole is 350 nm by using a 5Ω x 4.6 x 250nm column with a flow rate of 1 ml/min both Domperidone and Lansoprazole showed good response at 289 nm wavelength. Chromatogram for Domperidone is shown in figure 2.

 

Analysis of laboratory mixture:

 

Figure 2: Chromatogram showing Retention Time (Rt) of (a) 16 μg ml−1 of Domperidone. (4.380 min) and (b) 12μg ml−1 of LANS. (5.827 min) in laboratory-prepared mixture

 

Method Validation:

Linearity:

The linearity of Domperidone and Lansoprazole was determined by analytical procedure (HPLC) in which nine concentrations of each Domperidone from the range 4-36 mg/ml and Lansoprazole 2-18mg/ml were selected. The graph was plotted between area v/s analyte concentration as shown in figure 3 and 4 of Domperidone and Lansoprazole respectively7,8.

 

Figure 3: Linearity Curve of Domperidone

 

Figure 4: Linearity Curve of Lansoprazole

 

Precision:

Intermediate precision and repeatability measurement of peak area, retention time for each ingredient were determined by HPLC method (Table 1). The Repeatability, three replicates with in-day for five concentration and interemediate precision, 3 day for five concentrations9.

 

Table 1: Precision study results of prepared binary mixture

Validation parameter

HPLC

% RSD

Repeatabilitya

Peak area

Peak asymmetry

Retention time

DOMP.

69.146

0.5183

0.0810

LANS.

69.560

1.277

0.3635

Intermediate precisionb

Peak area

Peak asymmetry

 Retention time

DOMP.

70.256

0.7707

0.0948

LANS.

70.332

1.5508

0.3937

 

Table 2: Application of standard addiction technique to the analysis of Domperidone and Lansoprazole in Lans.pro-D Capsules

Sr. No.

Domperidone

Lansoprazole

Concentration in   µg ml-1

% Recovery ± SDa

Concentration in µg ml-1

% Recovery ± SDa

Claimed

Added

HPLC

Claimed

Added

HPLC

1

6

0

100.1 ± 0.738

6

0

99.75 ± 0.63

2

6

4

101.03 ± 1.8

6

2

100.475± 0.01

3

6

8

99.96 ± 0.72

6

4

101.02 ± 0.35

4

6

12

100.6 ± 0.91

6

8

99.84± 0.59

5

6

24

99.00 ± 1.1

6

10

100.55 ± 0.97

6

6

28

100.32 ± 0.91

6

12

99.94 ± 0.06

 

Accuracy:

The proposed HPLC10 analysed the increasing normal addition of known quantities of studied drugs to an unknown formulation concentration and resulting mixtures. Application of the traditional addiction procedure to Lans.pro-D Capsules for the study of Domperidone and Lansoprazole are given in table 2.

 

Ruggedness:

The robustness of an analytical method was calculated by aliquots from homogeneous lots using operating and environmental conditions that may vary, but assay parameters are specified (Table 3).

 

Table 3: Ruggedness report of Domperidone and Lansoprazole

Parameter

Result observed

DOMP.

LANS.

Percentage Area

100.406%

99.124%

SD between set of analysis on same date

1.423

1.430

SD between set of analysis on different date

1.651

1.684

RSD between set of analysis on same day

1.417%

1.139%

RSD between set of analysis on different days

1.754%

1.647%

 

Robustness:

The robustness of the method was determined by making slight changes in the chromatographic conditions.

Apparent PH of the mobile Phase (± 0.3)

Mobile Phase organic content (± 3%)

Mobile Phase flow rate (±0.6 ml/min)

Detection Wave length (±2nm)

 

RESULT AND DISCUSSION:

Domperidone & Lansoprazole retention times were found to be 4.330 ± 0.003 min and 5.820 ± 0.002 min. Mobile phase acetonitrile: ammonium acetate (54:49 v / v), with a flow rate of 1.0 ml min-1 calibration was linear with a concentration range of 4-36 mg ml-1 and 2-18 mg ml-1, with a regression of 0.996 and 0.9984, intercepts of 10.225 and 8.2212, and slopes of 25.956 and 34.627, respectively, for domperidone and lansoprazole. The low R.S.D percent value suggests that the process is reliable and precise. The mean recoveries were found in the range of 98-102 percent. The percentage of R.S.D reported was found to be less than 2 percent ion performance, showing adequate accuracy , precision, linearity, robustness, which were found to pass all acceptance criteria.

 

CONCLUSION:

For simultaneous determination of Domperidone and Lansoprazole, a simple RP-HPLC method with UV detection has been developed. For precision , accuracy and linearity, the method was validated. In the assay results of pharmaceutical formulation as well as in laboratory prepared mixtures by the established method in the 4-18 mg ml-1 linearity range, good agreement was seen. It can be concluded that the proposed method was a successful approach to achieving accurate results and was found to be sufficient for routine pharmaceutical formulation estimations of Domperidone and Lansoprazole.

 

ACKNOWLEDGEMENT:

The Authors are grateful to Micro Labs, Banglore for sending the gift samples of Domperidone and Lansoprazole. The author would like to thank Mr. Sanjeev Govind Rao Q.C Executive {Saar Biotech, Baadi, Solan (H.P)} For Providing guidance and necessary facilities to carry out research work.

 

CONFLICTS OF INTEREST:

The authors declare no conflict of interest.

 

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Received on 31.08.2020            Modified on 21.12.2020

Accepted on 04.02.2021           © RJPT All right reserved

Research J. Pharm.and Tech 2021; 14(12):6475-6478.

DOI: 10.52711/0974-360X.2021.01119