ESTIMATION OF GLIPIZIDE IN COMMERCIAL DRUGS BY RP – HPLC
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Transcript of 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
Journal of Atoms and Molecules An International Online JournalAn International Online JournalAn International Online JournalAn International Online Journal ISSN ISSN ISSN ISSN –––– 2277 2277 2277 2277 –––– 1247124712471247
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
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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
Jamonline /Jan-Feb 2(1) / 103–108 Lakshman Raju B & Rajesh G
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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
Jamonline /Jan-Feb 2(1) / 103–108 Lakshman Raju B & Rajesh G
All rights reserved© 2011 www.jamonline.in 104
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
Jamonline /Jan-Feb 2(1) / 103–108 Lakshman Raju B & Rajesh G
All rights reserved© 2011 www.jamonline.in 105
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
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All rights reserved© 2011 www.jamonline.in 106
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
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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.
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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.