INTRODUCTION:

Triamicinolone is chemically 9α-fluoro-11β, 16α, 17α, 21-tetrahydroxy-1, 4-pregnadiene-3, 20-dione and is official in Indian and British pharmacopoeia. Triamicinolone is a corticosteroid and is used in ocular diseases. However, repeated intravitreal or subconjunctival applications are necessary to maintain effective concentrations of the drug in the local tissues. Moreover, repeated injections are very traumatic for the patients and may have serious adverse effects, such as hemorrhages, eye infections and damage to the lens or retina [1-4]. It is also used to relive the discomfort of mouth sores [5]. Literature survey reveals that a few analytical methods have been reported for its quantitative estimation in pharmaceutical formulation, which include U.V. and HPLC methods [6-10]. In view of the above fact, some simple analytical methods are need for its quantitative estimation. In the present work a simple sensitive, economical and accurate Spectrophotometric methods have been developed for the quantitative estimation of Triamcinolone in Solid dosage form.

EXPERIMENTAL:

Chemical and Material

The pharmaceutical grade of Triamicinolone was supplied as a gift samples by Decoct Pharmaceutical PVT. Ltd. Delhi.

The tablet sample of Triamicinolone (Tricot-4) was procured from local market. All the chemical used were of analytical grade from Himedia, Mumbai. Double distilled water and methanol.

Instrument

A Shimadzu UV/Vis double beam spectrophotometer (model 1700 Pharma-SPEC) with 1 cm quartz cells was used for all spectral measurements.

Standard and Sample Preparation

Standard solution of Triamcinolone was prepared by using 25 mg bulk drug and dissolved in 50 ml of methanol. Then 4 ml of above solution was diluted to 500 ml to produce 4 mcg/ml with double distilled water. For sample solution the tablet of Triamcinolone were accurate weighed and average weight per tablet was determined. The tablets were powdered and powdered equivalent to 25 mg of drugs was taken and prepared in a similar manner that of standard.

RESULT AND DISCUSSION:

The absorbance was measured at 238nm against blank. Calibration curve was prepared by plotting concentration versus absorbance and found to be linear in the concentration range 3-9 mcg/ml. similar absorbance of sample solution was measured and amount of Triamcinolone was determined from standard calibration curve.

Method Validation

The describe method has been validated for the assay of major components of the bulk drug using following parameters [11] (table-1).

Table-1.

Parameters	Triamcinolone
Linearity Range (µg/ml)	3-9
Correlation Coefficient (r²)	0.9998
Ruggedness (%RSD)	0.2192
Robustness (%RSD)	0.4300

Specificity and Selectivity

Specificity and selectivity were studied for examination of the presence of interfering endogenous components, a reference solution containing Triamcinolone was prepared and was compared with blank. Result indicates that the retention time of Triamcinolone at 218nm and none of the impurities were interfering in its assay. The results of assay were compiled in Table No. 2

Table No. 2 Specificity of Method

S. No.	Bulk Drug
S. No.	Actual Amount Claim (in mg.)	Found (in mg.)	% Claim
1 2 3	25.14 25.21 25.05	25.20 25.03 25.11	101.24 99.29 100.24
		Mean	100.26

Linearity

Linearity was studied by preparing standard solution sets of different concentration level. The linearity range was found to be 3-9µg/ml. calibration curves containing the standard of 3µg/ml to 9µg/ml were used for the determination of the linearity of the Triamcinolone.

Accuracy

Accuracy was determined by recovery studies of Triamcinolone, known amount of Triamcinolone reference standard was added it to preanalyzed sample and subjected them to the proposed HPLC method. Results of the recovery study were shown in Table No. 3. The study was carried out at three different concentration levels.

TABLE No. 2 Recovery Study of Triamcinolone

Label Claim (mg)/Tablet

Amount Added (mg)

Amount recovered* (mg)

% Recovered

Triamcinolone 10mg

5.0

10.1

15.1

20.1

30.1±0.04

35.2±0.05

40.0±0.01

44.9±0.07

100.33

100.28

99.75

99.56

Mean

99.98

*Each value is mean deviation of three determinations

Precision

Precision was studied to find out intraday and inter-day variation in test methods of Triamcinolone in the concentration ranges of 20µg/ml to 200µg/ml. for three times on the same day and later day. Precision was determined by analyzing corresponding standard daily for a period of three days. The %RSD in case of intra-day and inter day was found to be 0.8182 and 0.9438 respectively.

Stability

Stability of reagents, mobile phase, standard and sample solutions were studied for 48 hours and compared with the freshly prepared solutions and was found to be stable.

CONCLUSION:

The method described in this paper for the estimation of Triamicinolone is found to be simple, sensitive, accurate, precise, rapid and economical. The value of standard deviation and % RSD were indicating of the accuracy of the proposed method. Hence the method could be successfully employed for the routine analysis in their dosage form.

REFERENCES:

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2. Cardillo JA Melo Jr LAS Costa RA Skaf M Belfort Jr R Souza-Filho AA Farah ME Kuppermann BD Comparison of intravitreal versus posterior sub-tenon’s capsule injection of triamcinolone acetonide for diffuse diabetic macular edema. Ophthalmology 112; 2005:1557-63.

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11. International Conference on Harmonisation, (1996) Guidance for Industry in: Q2B Validation on Analytical Procedures. Methodology Switzerland IFPMA, 1.

Received on 01.04.2013 Accepted on 18.05.2013

Asian J. Pharm. Ana. 3(2): April- June 2013; Page 42-43