A REVIEW ON ANALYTICAL METHOD FOR DETERMINATION OF INDAPAMIDE IN MARKETED PHARMACEUTICAL PREPARATION

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ABOUT AUTHORS
Patil N.B.*, Patil K.B., Wagh M.N., Patil A. A.
Department of Pharmacy,
Ahinsa Institute of pharmacy,
Dondaicha Tal-Shindakheda Dist-Dhule, Maharashtra, India

ABSTRACT
Indapamide is the Thiazide like diuretic drug used in treatment of Hypertension, as well as odema, Heart attack, stroke and heart failure in persons with high blood pressure. It is available in market single component and multicomponent formulations. The article summarizes 57 analytical method including the chromatographic method, LC-MS (Liquid Chromatography-mass spectroscopy), GC-MS (Gas chromatography-mass spectroscopy), spectriflurometric and UV Visible spectrophotometry techniques for estimation of   Indapamide in biological samples, bulk and pharmaceutical formulation.

Reference Id: PHARMATUTOR-ART-2633

INTRODUCTION:
Indapamide is thiazide like diuretic drugs used in treatment of Hypertension, as well as odema, Heart attack, stroke, Heart Failure Patient with high blood pressure .Indapamide is an available in combination and single pharmaceutical dosage forms. [https://en.m.wikipedia.org, Tripathi K.D.2013]

Chemistry:-
Indapamide is diuretic class of drug .It is chemically 3-(amino sulfamoyl)-4-chloro-N-(2,3-dihydro-2-methyl-1H-indol-1-yl)benzamide.the molecular formula is C16H16ClN3O3S and molecular mass is 365.8 g/mol. Indapamide is white crystalline powder, odorless and it is soluble  in methanol, ethanol, acetic acid, ethyl acetate and very slightly soluble in chloroform.[https://en.m.wikipedia.org]

Fig.1. chemical structure of Indapamide

Pharmacology
1. Mechanism of Action:-
 Indapamide Control Hypertension in part By inhibiting  reabsorption of sodium (Na+) and chloride(Cl-) ions from distal convoluted  in the kidneys by  convoluted tubules in the Kidneys by blocking the Na+-Cl- symporter.[http:/www.sciencedirect.com]
2. Pharmacokinetics:-
Absorption of Indapamide from the gastrointestinal tract is rapid within 0.5 to 1 hour after an oral dose .It is plasma protein binding 79% and plasma elimination Half-life of Indapamide 16 Hours.[ http:/www.sciencedirect.com]
3. Dosage Forms & Recommended Doses:-    
Oral Formulations of Inapamide Available in India .The recommended Dose single Daily 2.5mg. [ Tripathi K.D.2013]
4. Adverse Effect:-
In  general most adverse effect are Dizziness,Headache,Fatigue,Muscle Cramps ,Asthenia ,GIT  disturbances ,Electrolyte Imbalance (Hypokalemia  ,Hypochloramia, Hyponatremia)[ https://en.m.wikipedia.org, Tripathi K.D.2013]
5. Contraindications:-
Indapamide is contraindicated in Sulphonamides, Severe Kidney Failure, Hepatic encephalopathy, low Blood Potassium level and pregnancy or Breastfeeding.

Analytical Method:-
This all are method which are used for determination of   Indapamide in Pharmaceutical formulation and in biological fluids. This are all analytical method are reported during the literature survey. This all reported analytical method with specific condition.  Indapamide is a commonly used in the treatment of Hypertension. the literature reports vast number of analytical methods such as UV spectrophotometry, HPLC( High performance liquid chromatography),HPTLC( High performance thin layer chromatography) ,GC-MS (Gas chromatography -mass spectroscopy),LC-MS (Liquid chromatography -mass spectroscopy) for the determination of Indapamide in Biological matrices, Bulk material and the pharmaceutical Dosage Formulation. The Objective this review to assemble the analytical method published for analysis of Indapmide in Biological matrices, Bulk and pharmaceutical formulation.
1.  Spectrophotometry:-
In the literature survey were found that 12 UV spectrophotometric methods have been reported for estimation of Indapamide Single and in combined dosage form.
Table.1 illustrates the summery of the reported UV spectrophotometric methods indicating sample matrix used, Lambda Max, linearity range.

Table no.1 Summary of UV spectroscopic  methods of Indapamide

Where-
[AUC-Area under curve; ADB-Amlodipine Besylate; ATN-Atenolol; TEL-Telmisarthan; IND- Indapamide; PNP-Perindopril]

2. Chromatographic Method:-
The High performance liquid chromatography (HPLC) for residue determination of single and combination drug and also used in impurity profiling. High performance liquid chromatography (HPTLC) methods used in analysis of  Indapamide in pharmaceutical dosage form.

Table no.2 shows the summarize reported chromatographic method indicating sample, method, mobile phase and wavelength.

Table no. 2 summary chromatographic method of Indapamide

Where -
[IND-Indapamide; RP-HPLC- Reverse phase high performance liquid chromatography; HPLC- High performance liquid chromatography; HPTLC-High performance liquid chromatography; ADB-Amlodipine Besylate; AML-Amlodipine ;ATN-Atenolol; DCM-Dichloromethane ;GAA-Glacial acetic acid ;IPLC-Ion pair liquid chromatography ;KH2PO4-Potassium dihydrogen orthophosphate ;LSP-Lisinopril; NBL-Nebivolol OLM-Olmisarthan; OPA-Orthophosphoric acid; PDP-Potassium dihydrogen phosphate ;PNP-Perindopril ;PNPE-Perindopril Ebrumine ;RP-UPLC-Reverse phase –Ultra performance liquid chromatography ;SDS-Sodium dodecyl sulphate ;TEL-Telmisarthan ; UPLC-Ultra performance]

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3. Spectroflurometric method:-
The spectroflurometric determination of   Indapamide the first and second method are based on the oxidative coupling reaction of Indapamide with 3-methyl-2-benzothalidone hydrazine Hcl in presence of cerium ammonium sulphate in acidic medium and quenching effect on fluorescence of excess cerous ions at the emission  max 350 nm and the excitation at max 300nm with linearity 1.2 to 9.6µg/ml with recovery 99.27% [Nadia F. Youssef et al., 2003.].

A sensitive fluorescence method for determination  of  Indapamide  reaction of Indapamide  with sodium hydroxide and addition of formaldehyde, linearity of  0.025 to 2.0 µg/ml the concentration of  Indapamide of 0.05µg/ml can be detected in Dog  given  20 mg of drug .the fluorescence at emission  max 356nm and excitation max  284nm [Peter E.Grebow et al.,1978.].   

4. GC-MS (Gas chromatography - mass spectroscopy) Method:- 
A sensitive method  of GC-MS of  Indapamide SIM window 2.885 with separation Ions at 132,161,322,336,337,407 m/z & Dwell time is 40 [Claudio Brunelli et al.,2006.].
The determination of Indapamide in human urine using GC-MS & the retention time is 7.465 min. with segment range 7.2-7.9 min. and separation at Ions 407 m/z.[Olga Zaporozhets et al.,2012.].

5.  LC-MS (Liquid chromatography-mass spectroscopy) Method:-
A sensitive method using LC-MS for the determination of indapamide in Human blood separation were performed on a symmetry c18 column (150×3.9mm id, 5µm) with mobile phase Acetonitrile: Water (60:40 v/v) Indapamide and IS(propyl paraben) were detected at m/z 364 for Indapamide and m/z 179 for propyl paraben with linear calibration range 2.0-120µg/ml.[Jingling Tang et al.,2005.]
A sensitive LC-MS method for the determination of Indapamide in human plasma using was separated on a C18 column with mobile phase 10mM Ammonium acetate: Methanol (22:78 v/v). Indapamide were estimated that by using Electrospray ionization the selected ions monitoring mode using target ions at m/z 364.3 for Indapamide and m/z 492.4 for the IS with linearity 0.1-100ng/ml for Indapamide. The mean   recovery   90.5-93.95%. [Li Ding et al., 2006.]
A simple, sensitive and rapid LC-MS method for Quantification of Indapamide in human plasma the compound were separated on a stainless steel column (C18 shim-pack 5µm 150×2.0mm I.D., shimadzu) and separated ions monitoring at m/z 364.0 Indapamide and chlorpropamide m/z 275.0 with linear range 0.5 to 100ng/ml with a coefficient of determination(r) of 0.9998. [Yan Liang t al., 2006.]

6. Stability indicating method:-

Table no.3 summary stability indicating   method of Indapamide

Where- [CP-Captopril; IND-Indapamide; ATN- Atenolol; HPLC- High performance liquid chromatography]

CONCLUSION:
This reviews articles presented the analytical methods for the estimation of Indapamide & its combination  in pharmaceutical dosage form and biological sample like Blood, serum or plasma the literature survey of analytical data exhibit that HPLC methods are primarly for the analysis of Indapamide in single and in combination with other drugs in various formulation type of dosage form the other analytical methods like RP-HPLC, HPTLC, LC-MS, GC-MS, UV spectrometry,spectrofluorometry and stability indicating methods by HPLC used for the estimation of Indapamide in single and its combined dosage form, biological sample like blood,serum or plasma and milk.   The presented information is useful for future prospective study for researcher in formulation development, Bio analytical research and Quality control of Indapamide.

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