A REVIEW: ANALYTICAL METHODS FOR DETERMINATION OF CILNIDIPINE IN BIOLOGICAL FLUID AND PHARMACEUTICAL DOSAGE FORMS

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ABOUT AUTHORS:
Farhana V. Buchiya*, Vineet Jain, Hasumati Raj
Shree Dhanvantary Pharmacy College,
Kim, Surat, Gujarat
buchiyafarhana22@gmail.com

ABSTRACT:
Cilnidipine is act as a  dual blocker by blocking L- type of calcium channel  present in vascular smooth muscles and  N- type of calcium channel  present in sympathetic nerve  terminal that supply  blood  vessels. Cilnidipine used in treatment of mostly in hypertension and various cardiovascular diseases except in Angina. Cilnidipine used alone or in combination. This review covers most recent analytical methods such as various spectroscopic methods, chromatographic methods and other methods for determination of cilnidipine in various pharmaceutical dosage forms and biological matrix were reported.

REFERENCE ID: PHARMATUTOR-ART-2275

PharmaTutor (ISSN: 2347 - 7881)

Volume 2, Issue 11

Received On: 10/09/2014; Accepted On: 18/09/2014; Published On: 01/11/2014

How to cite this article: FV Buchiya, V Jain, R Hasumati; A Review: Analytical Methods for Determination of Cilnidipine in Biological Fluid and Pharmaceutical Dosage Forms; PharmaTutor; 2014; 2(11); 22-29

INTRODUCTION:
Cilnidipine (CIL) 1,4- Dihydro- 2,6- dimethyl- 4-(3-nitrophenyl)-3,5-pyridinecarboxylic acid 2-methoxyethyl(2E)-3-phenyl-propenyl ester is a novel and unique dihydropyridine calcium channel blocker that possesses a slow-onset, long-lasting vasodilating effect.(1)


Chemical Structure of Cilnidipine

Table No: 1 Drug Profile (2-5)

         PARAMETERS

 DESCRIPTION

Category

Calcium channel antagonist

Molecular Formula

C27H28N2O7

Molecular Weight

492.52 gm/mol

Characteristics

Yellow crystalline solid

Solubility

Soluble in DMSO (> 25 mg/ml), ethanol (20 mg/ml), water (≤ 2 mg/ml), and methanol.

Dose

Adult: 5-10 mg once daily, increase to 20 mg once daily if necessary.

MECHANISM OF ACTION: (6-7)
Cilnidipine is a dual blocker of L-type voltage-gated Ca2+ channels in vascular smooth muscle and N-type Ca2+ channels in sympathetic nerve terminals that supply blood vessels.The inhibition of N-type Ca2+ channels may provide a new strategy for the treatment of cardiovascular diseases. L-type calcium channels are the main targets of the CCB. N-type calcium is distributed along the nerve and in the brain, cilnidipine is anticipated to exert specific action on nerve activity, such as inhibition of the sympathetic nervous system. It inhibits the Ca2+ influx in both in vessel & in the nerve. So causes the Vasodilation & inhibits the release of nor epinephrine, which causes the Vasodilation and decreases the heart rate & also decreases cardiac contraction in heart. So, used in treatment of hypertension


Fig 1:  Diagrammatic representations of Dual Action of Cilnidipine (7)

PHARMACOKINETIC PARAMETERS:

Table No: 2 Pharmacokinetic Parameters of Cilnidipine

PARAMETERS

DESCRIPTION

Absorption

Orally absorbed

Metabolism

Hepatic. Metabolised extensively (90%) to inactive metabolites via the cytrochrome P450 3a4 iso enzyme.

Excretion

Urine

Peak Plasma Concentration

6-12 hour following oral administration. Bioavailability is 64-90%.

SIDE EFFECTS:(8)
Dizziness; flushing; headache; hypotension; peripheral oedema; tachycardia; palpitations; GI disturbances; increased micturition frequency; lethargy; eye pain; depression; ischaemic chest pain; cerebral or myocardial ischaemia; transient blindness; rashes; fever; abnormal liver function; gingival hyperplasia; myalgia; tremor; impotence.

COMBINATION OF CILNIDIPINE:
Cilnidipine + Telmisartan
Cilnidipine + Olmesartan medoxomil
Cilnidipine + Metoprolol Succinate

MARKETED FORMULATION OF CILNIDIPINE:

Table No: 3 Marketed Formulation of Cilnidipine(9)

Sr. No.

Brand Name

Company Name

Formulation

Dose (mg)

1

Cilcar

United pharmacies

Tablet

5,10

2

Cilnidipine tablet

Actza pharmaceutical

Tablet

250

3

Cilcar

J.B. Chemicals &

Pharmaceuticals Ltd.

Tablet

5,10,20

ANALYTICAL METHOD:
This all are the methods which are used for the determination of Cilnidipine in marketed formulation and in biological fluids. This all analytical methods are reported which are seen during the literature survey. This article describes the review on the all reported analytical methods with specific conditions.

A. COMPENDIALMETHOD:
Cilnidipine is not official in any pharmacopeia.

B. REPORTED METHOD:
1.
CHROMATOGRAPHIC METHODS:
Various chromatographic methods are used for the determination of the Cilnidipine alone or combination with other drugs in various marketed formulation and in biological fluids like human plasma. Chromatographic methods like Reverse phase High performance liquid chromatography (RP-HPLC) & High performance thin layer chromatography (HPTLC) are used for determination of Cilnidipine. Below in table describes the summary of the various chromatographic methods are used with the method description.

Table No.4: Summary of Chromatographic Methods of Cilnidipine

Title

Method

Mobile Phase

Stationary Phase

Wavelength  (nm)

Ref.

Simultaneous estimation of telmisartan and cilnidipine in bulk and in tablet formulation using RP-HPLC

RP-HPLC

Buffer: methanol: Acetonitrile  (30:40:30 v/v/v)

INERTSIL ODS C18 (250 x 4.6 mm, 5μ, Make: GL Sciences) pre packed column.

232

10

Simultaneous RP-HPLC estimation of cilnidipine and telmisartan in

combined tablet dosage form

RP-HPLC

Methanol: 40 mM Potassium dihydrogen ortho phosphate buffer (pH 3) (90:10  v/v))

HiQ sil C18 HS column (250 × 4.6 mm i.d.) and PDA detector

245

11

Development and validation of analytical method for simultaneous estimation of Cilnidipine and Olmesartan Medoxomil in bulk and tablet dosage form by RP-HPLC

RP-HPLC



Methanol: 40 mM Potassium dihydrogen ortho phosphate buffer (90:10 v/v)

HiQ sil C18 column (250 × 4.6 mm i.d.) and PDA detector

252

12


RP-HPLC

 Acetonitrile: Water (90:10 v/v)

Shimandzu Phenomenex-luna C18 (250 x 4.6mm, 5 μ)

231

13

Development and validation of high performance thin layer chromatographic

Method for Cilnidipine and Metoprolol S Succinate in their combined

Pharmaceutical dosage form

HPTLC

Chloroform: Ethyl acetate: Methanol: Triethylamine

9:2:0.5:0.5 v/v/v/v.

Silica gel F254 TLC plates

280

-

14

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