ESTIMATION OF GLIPIZIDE IN COMMERCIAL DRUGS BY RP – HPLC

Jamonline /Jan-Feb 2(1) / 103–108 Lakshman Raju B & Rajesh G

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Research Article

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ESTIMATION OF GLIPIZIDE IN COMMERCIAL DRUGS BY RP – HPLC

Lakshman Raju Badugu1*, Rajesh Gunti1 1M.Sc 2008 – 10 Batch Students, Department of Chemistry, Bhagwan Sri Satya Saibaba PG

College, Tadikonda, A.P, India

Received on: 10-01-2012 Revised on: 18-02-2012 Accepted on: 23–02–2012

Abstract:

Glipizide is used together with diet and exercise to reduce blood glucose in patients with type 2

diabetes. Recommended starting dose is Glipizide 5 mg, taken once daily before breakfast. For

elderly people or people with liver problems, the recommended starting dose is lower. A Glipizide

overdose can cause low blood sugar (hypoglycaemia), Sweating Shakiness, Extreme hunger,

Dizziness, Cold sweats, Blurry vision. The present study is used for the determination of the assay

of Glipizide in the commercial samples. Among those Glicept contains maximum amount of

Glipizide.

Key Words:

Glipizide, HPLC, Assay, Otsira, Glicept.

Introduction:

Glipizide is an oral medium-to-long

acting anti-diabetic drug from

the sulfonylurea class. It is classified as a

second generation sulfonylurea, which means

that it undergoes enterohepatic circulation.

The structure on the R2 group is a much

larger cyclo or aromatic group compared to

the 1st generation sulfonylureas.

* Corresponding author

Lakshman Raju Badugu,

Email: [email protected]

Tel: + 91 – 9866508397



Drug Stricture

Figure 1.1: stricture of Glipizide.

IUPAC Name: N-(4-[N-

(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-

5-methylpyrazine-2-carboxamide

Insulin is a hormone that is made in the

pancreas that, when released into the blood

causes cells in the body to remove sugar

(glucose) from the blood and reduces the

formation of glucose by the liver. Patients

with type 2 diabetes have high glucose (sugar)

levels in their blood because the cells in their

bodies are resistant to the effect of the insulin,

and the liver produces too much glucose. In

addition, in type 2 diabetes the pancreas is

unable to produce the increased amounts of

insulin that are necessary to overcome the

resistance. Glipizide reduces blood glucose by

stimulating the pancreas to produce more

insulin. Glipizide is not a cure for diabetes.

The usual starting dose when using immediate

release tablets is 5 mg administered 30

minutes before a meal. The maximum dose is

40 mg daily. Doses higher than 15 mg per day

should be divided. Side effects

include headache, dizziness, diarrhea, and

gas. Skin rashes can occur and cause

itching, hives, or a diffuse measles-like rash.

Rare but serious side effects include

hepatitis, jaundice, and a low sodium

concentration. Glipizide may also cause

hypoglycemia. The risk of hypoglycemia

increases when glipizide is combined with

other glucose reducing agents.

Materials and methods

Methanol, Acetonitrile and Water used were

HPLC Grade and were purchased from

MERK Chemicals PVT LTD. For analysis of

Drug, PEAK 7000 isocratic HPLC with

fallowing configuration is used.

Peak 7000 delivery system.

Rheodyne manual sample injector with

switch (77251).

Analytical column Kromosil 100-5

C18.250*46mm.

Preparation of Mobile phase

The suitable mobile phase for the estimation

of Glipizide consist of Methanol : Acetonitrile

: Water 40:40:20(v/v/v).

Preparation of Standard Solution

The standard drug sample were obtained from

Torrent pharma, India. About 1 mg of

Glipizide standard was accurately weighed

and transferred into 10ml volumetric flask and

makeup with sufficient mobile phase. The

volumetric flask containing standard solution

kept for sonication for 10min and is filtered



Drug Stricture










































switch (77251).


C18.250*46mm.




: Water 40:40:20(v/v/v).











Drug Stricture










































switch (77251).


C18.250*46mm.




: Water 40:40:20(v/v/v).











through 0.45um Nylon 6,6 membrane filtered

paper.

Preparation of Sample Solution:

Different formulations of Glipizide were

purchased from local market and is dissolved

in appropriate amount of mobile phase , the

solution kept for sonication for 10min and is

filtered through 0.45um Nylon 6,6 membrane

filtered paper and is used as sample for

analysis.

Procedure for analysis:

Optimized chromatographic conditions for

analysis of Glipizide are given the table 1.

With the optimized chromatographic

conditions for the HPLC were set for

Glipizide, a study base line was recorded.

After the stabilization of the base line for

about 30min, successive aliquots of the

sample solution were injected separately and

chromatograms were recorded. This

procedure was applied for every commercial

sample.

Results and discussion:

The standard chromatograms and sample

were shown in figure 1.2 and 1.3.

The assay for different commercial samples of

Glipizide were estimated by using the

fallowing formula, and results were shown in

table 1.A

Conclusion:

The concentration of Glipizide in Glicept is

maximum when compare to other samples, It

contain 91.4% of Glipizide, where as the

concentration is minimum inGlimet, it contain

63% of Glipizide. Maximum number of

impurities were detected in Gynase. The over

dosage of Glipizide causes side effects like

low blood sugar (hypoglycemia), Sweating

Shakiness,Extreme hunger, Dizziness,Cold

sweats, Blurry vision. so people can aware of

these chemical composition in the

commercially available forms and use the

proper dosage for their better recovery and

reduce the side effects.

References:

1 Swaroop R. Lahoti, Prashant K, Puranik,

Ashish, A. Heda, Development and

Validation of RP-HPLC Method for

Analysis of Glipizide in Guinea Pig

Plasma and its Application to

Pharmacokinetic Study.

2 Håkan Emilsson, High-performance liquid

chromatographic determination of

glipizide in human plasma and urine,

Journal of Chromatography B: Biomedical

Sciences and Applications Volume 421,

1987, Pages 319-326.

3 Bae, Jung-Woo; Kim, Nam-Tae; Choi,

Chang-Ik; Kim, Mi-Jeong; Jang, Choon-

Gon; Lee, Seok-Yong, HPLC Analysis of

Plasma Glipizide and its Application to

Pharmacokinetic Study, Journal of Liquid



Chromatography & Related Technologies,

Volume 32, Number 13, January 2009.

4 Gupta S, Bansal G, Validated stability-

indicating HPLC-UV method for

simultaneous determination of glipizide

and four impurities, J AOAC Int. 2011

Mar-Apr;94(2):523-30.

5 S.D. Jadhav, A.V.Chandewar,R.L.

Bakal,A. Dewan, Development Of Hplc

Method And Validation For The

Estimation Of Glipizide And Metformin

Hydrochloride In Combined Dosage

Form.International Journal of Pharma

Vol 2, No. 2,March -June 2011

6 Xiao-Hua Zhao, Bo Song, Da-Fang

Zhong, Shu-Qiu Zhang, Xiao-Yan Chen,

Simultaneous determination of metformin

and glipizide in human plasma by liquid

chromatography-tandem mass

spectrometry, Yao xue xue bao Acta

pharmaceutica

Sinica (2007),Volume: 42, Issue: 10, Page

s: 1087-1091.



S.No Parameter Condition

1 Mobile phase Methanol:Acetonotrile:Water

(40:40:20)

2 Column Kromosil C18

3 Wavelength 256nm

4 Injection volume 20ul

5 Run time 6 min

6 Flow rate 1ml/min

7 Retention time 3.62

8 Temperature Ambient

9 Pump pressure 3000psi

Table 1: Optimim Conditions of Chromatography

Figure1.2: standard chromatogram of Glipizide.



Figure1.3: sample chromatogram of Glipizide (Brand name:Bigunyl).

S.No Sample RT %Assay

1 Standard 3.62 100

2 Otsira 3.60 86.109

3 Bigunyl 3.79 70.101

4 Glicept 4.32 91.398

5 Glimet 4.12 62.914

6 Gynase 3.81 75.627

7 Dlipizide 3.58 76.516

Table 1.A: Assay results of Glipizide in different commercial formulations.

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ESTIMATION OF GLIPIZIDE IN COMMERCIAL DRUGS BY RP – HPLC