Research Articles

Jan - Feb 2018  |  Vol: 4  |  Issue: 1
UV Spectrophotometric Method Development and Validation for Quantitative Estimation of Venlafaxine hydrochloride

*Sagar Kishor Savale

 

*Department of Pharmaceutics, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur 425-405, dist. Dhule, Maharashtra, India

 

*Corresponding author,

Mr.Sagar Kishor Savale,

Department of Pharmaceutics,

R. C. Patel Institute of Pharmaceutical

Education& Research, Shirpur, 425405,

 dist. Dhule, Maharashtra, India.

Mobile No: +91 9960885333,

Email ID: avengersagar16@gmail.com

 

 

 

ABSTRACT

Aim:  UV Spectrophotometric Method Development and Validation for quantitative estimation of Venlafaxine hydrochloride.Objective:  U.V Spectrophotometric method have been widely employed for determination of analyte in a mixture. Our aim is to develop spectroscopic method for estimation of the Venlafaxine hydrochloridein ternary mixture by using U.V spectrophotometry. Methodology: The method was validated as per ICH guidelines. The recovery studies confirmed the accuracy and precision of the method. Conclusion: It was successfully applied for the analysis of the drug in bulk and could be effectively used for the routine analysis.

Key words:Venlafaxine hydrochloride, UV spectrophotometric method, Validation.

 

 

 

Introduction

Venlafaxine hydrochloride is an anti-depressant agent andchemically it is a cyclohexanol hydrochloride derivative. ItsIUPAC name is [R/S]-1-[2-dimethylamine)-1-[4-Methoxyphenyl) ethyl] cyclohexanol hydrochloride or (+)-1-[2-[(dimethyl amino) methyl] p-Methoxybenzyl] cyclohexanolhydrochloride. Venlafaxine is official drug in BritishPharmacopoeia.

 

The review of literaturerevealed that no method is reported for the Venlafaxinehydrochloride in fixed dosage products by UV-spectroscopy.The present paper describes a simple and accurate UV-spectrophotometric methodcan be highly useful for routine analysis of bulk, formulations anddissolution samples. (Baldania et al., 2008; Savale et al., 2017)

Material and Method

Material

Venlafaxine hydrochloride supplied as a gift sample From Lee Pharma Pvt. Ltd (Hyderabad, India) used as working standard.

Instrumentation

A double beam UV-VIS spectrophotometer (UV-1700, Shimadzu, Japan) connected to a computer loaded with spectra manager software UV Probe was used. The spectra were obtained with the instrumental parameters as follows: Wavelength range: 200–400 nm. All weights were taken on an electronic balance (Model Shimadzu AUX 120).

 

Reparation of standard stock solution

According to BritishPharmacopoeia, 10 mg of Venlafaxine hydrochloride was dissolve in 100 mL of phosphate buffer (pH 6.4) (100 µg/mL). Out of this stock 0.1-2.4 ml was pipetted and diluted up to 10 mL by phosphate buffer (pH 6.4)(1-24 µg/mL) and examined between 200-400 nm. The maximum absorbance was determined using UV-Vis Specrophotometer (UV-1700, Shimadzu, Japan) to confirm the λmax of the drugs (Savale et al., 2017).

Validation of analytical method

The analytical performance characteristics which may be tested during methods validation: % Recovery, Precision, Ruggedness and sensitivity (Karani et al., 2009; Savale et al., 2017).

Results and Discussion

Method Development

The solution of Venlafaxine hydrochloride in phosphate buffer (pH 6.4)was found to exhibit maximum absorption at 224 nm after scanning on the UV-Vis spectrophotometer which was reported as λmax in the literature and the procured drug sample of Venlafaxine hydrochloride complies with the reference spectra .

 

(Figure 1).

 

Figure 1. UV spectra of Venlafaxine hydrochloride

 

 

Validation of analytical method

Linearity

Accurately weighted Venlafaxine hydrochloride(10 mg) was dissolved in 100 ml of phosphate buffer (pH 6.4)to obtain working standard of 100 μg/ml. Aliquots were pipetted from the stock solution of drug and were transferred to 10 ml volumetric flask, the final volume was adjusted with phosphate buffer (pH 6.4)so that concentration of 1-24 μg/ml could be made. Absorbance of the above solution were taken at 224 nm by using UV-Vis spectrophotometer (UV-1700, Shimadzu, Japan) against the blank solution prepared in the same manner without adding the drug. A graph of absorbance vs concentration was plotted (Figure 2) and R2 was found to be 0.9986.

 

Figure 2. Calibration curve of Venlafaxine hydrochloride

 

 

Recovery

Recovery study is performed by standard addition method by adding the known amount of Venlafaxine hydrochloride(Working standard) at two different concentration levels i.e 80%, 100% of assay concentration and % recovery for all these drug were calculated. Result was reported in Table 1.

Table 1. Recovery study

 

 

 

 

Drug

Initial amount

(µg/ml)

Added Amount (µg/ml)

% Recovery

% RSD

(n = 3)

Venlafaxine hydrochloride

2

1.8

100.77

0.03

 

2

2

100.01

0.01

 

 

Precision

Intra-day precision was

 

 

 

 

determined by analysing, the two different concentrations 2 mg/ml, 3 mg/ml containing Venlafaxine hydrochloride, for three times in the same day (n = 3) Table 2. Inter-day variability was assessed using above mentioned three concentrations analysed on three different days, over a period of one week (n = 3) Table 2.

 

 

 

 

 

 

 

 

 

 

Table 2. Presion study

 

 

Intra - Day

Inter - Day

Drug

Con. (µg/ml)

Mean ± SD

% RSD

Mean ± SD

% RSD

Venlafaxine hydrochloride

2

2.0 ± 0.0044

0.08

2.0 ± 0.0088

0.01

 

3

3.0 ± 0.0075

0.02

 3.0 ± 0.0041

0.09

 

 

 

 

 

 

 

 

 

 

 

 

Ruggedness

From stock solution, sample solution containing Venlafaxine hydrochloride(2 µg/ml) was prepared and analyzed by two different analysts using similar operational and environmental conditions (Table 3) (n = 3).

 

 

 

 

Table 3. Ruggedness study

 

% Amount Found

% RSD

Drug

Analyst I

Analyst II

Analyst I

Analyst II

Venlafaxine hydrochloride

100.74

100.95

0.01

0.05

 

 

 

 

 

 

Sensitivity

Sensitivity of the proposed method were estimated in

terms of Limit of Detection (LOD) and Limit of Quantitation (LOQ) (Table 4).

 

 

 

Table 4. Sensitivity study

Drug

LOD

LOQ

Venlafaxine hydrochloride

0.48 ± 0.001

0.98 ± 0.016

 

 

 

 

 

Conclusion

The proposed UV spectrophotometric method was found very simple, rapid and economical. The method is validated in compliance with ICH guidelines is suitable for estimation of Venlafaxine hydrochloridewith excellent recovery, precision and linearity.

 

Reference

Baldania SL, Bhatt KK, Mehta RS. 2008. RP-HPLC estimation of Venlafaxine HCL in tablet dosage form. Indian J. pharm Sci, 70(1); 124-8.

Karani NA, Pingale p. 2009. Analytical method development & validation of venlafaxine hydrochloride in solid dosage forms using UV spectrophotometer. Journal of Pharmacy Research, 2(7): 1246-1249.

Savale S, Mahajan H. 2017. UV Spectrophotometric Method Development and Validation for Quantitative Estimation of Diclofenac Sodium. Asian Journal of Biomaterial Research, 3(2): 40-43.

Savale S. 2017. Simultaneous Determination of Curcumin and Gefitinib in Pure Form by Using UV Spectrophotometric Method. Hygeia: journal for drugs and medicines, 9 (1): 1-8.

Savale S. 2017. UV Spectrophotometric Method Development and Validation for Quantitative Estimation of Halcinonide. Asian Journal of Biomaterial Research, 3(3): 22-25.

 

 

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