ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SALMETEROL BY UV SPECTROSCOPY

About Authors:
Gunjan Kalyani*, Vishal S. Deshmukh, Pranita Kashyap, Yogesh Vaishnav, Ajit Kumar Pandey
Shri Rawatpura Sarkar Institute of Pharmacy,
Kumhari, Durg, Chhattisgarh.
kalyani.gunjan@yahoo.in, rvg_54767@yahoo.co.in*

Abstract:
The IUPAC Name of Salmeterol is (RS)-2-(hydroxymethyl)-4-{1-hydroxy-2-[6-(4-phenylbutoxy) hexylamino]ethyl}phenol. Salmeterol is a prescription drug that is used for treating airway spasms in people with asthma or chronic obstructive pulmonary disease (COPD). By relaxing the muscles around the airways to allow more air into and out of the lungs, the medication can help prevent asthma attacks from occurring.Salmeterol comes in the form of an inhalation powder and is generally used twice a day. Present research work deals with UV spectrophotometric method for the estimation of salmeterol in pure form. For the estimation of salmeterol, solvent system employed was ethanol and wavelength of detection (λdet) was 252 nm. The linearity was obtained in the range 6 – 14 µg/ml, with a regression coefficient, R2= 0.999. The LOD & LOQ were found to be 4.99 µg/ml and 14.24 µg/ml respectively. Obtained results showed that there is minimum intra day and inter day variation. The developed method was validated and recovery studies were also carried out. Sample recovery using the above method was in good agreement with their respective labeled claims, thus suggesting the validity of the method and non-interference of formulation excipients in the estimation.

REFERENCE ID: PHARMATUTOR-ART-1478

1. Introduction:
The IUPAC name of Salmeterol is RS)-2-(hydroxymethyl)-4-{1-hydroxy-2-[6-(4-phenylbutoxy) hexylamino] ethyl} phenol.

1.1 Mechanism of action
Salmeterol's long, lipophilic side chain binds to exosites near beta(2)-receptors in the lungs and on bronchiolar smooth muscle, allowing the active portion of the molecule to remain at the receptor site, continually binding and releasing. Beta(2)-receptor stimulation in the lung causes relaxation of bronchial smooth muscle, bronchodilation, and increased bronchial airflow.

Salmeterol is a prescription drug that is used for treating airway spasms in people with asthma or chronic obstructive pulmonary disease (COPD). By relaxing the muscles around the airways to allow more air into and out of the lungs, the medication can help prevent asthma attacks from occurring. Salmeterol comes in the form of an inhalation powder and is generally used twice a day. However, it can also be used 30 minutes before exercise to help prevent exercise-induced asthma attacks.


Literature review suggested no UV Spectroscopic method. The objective of the work was to develop simple, accurate, precise and economic second order derivative Spectroscopic method to estimate the candesartan in bulk. The method should be simple, accurate, precise, reproducible and statistically valid.

UV spectrophotometry is generally preferred especially by small-scale industries as the cost of the equipment is less and the maintenance problems are minimal. The method of analysis is based on measuring the absorption of a monochromatic light by colorless compounds in the near ultraviolet path of spectrum (190-380nm). The fundamental principle of operation of spectrophotometer covering UV region consists in that light of definite interval of wavelength passes through a cell with solvent and falls on to the photoelectric cell that transforms the radiant energy into electrical energy.

Thus, the objectives of project:
I. To develop a simple, precise, accurate method, less time consuming & economical derivative spectroscopic method.
II. Under derivative spectroscopy, the development of Second Order derivative Method.
III. Validation of developed method using common parameters:
a)      Linearity
b)      Precision
c)      Accuracy
d)     Sensitivity
e)      Limit of Detection (LOD)
f)       Limit of Quantification (LOQ)

2. Materials and Methods:
Year of experimentation: 2012
Site of experimentation: Shri Rawatpura Sarkar Institute of Pharmacy, Kumhari, Durg, Chhattisgarh.

2.1 Drug
The standard sample of Salmeterol was obtained as gift sample form Glenmark Pharmaceuticals, Solan, H.P., India.

2.2 Instrument specifications
UV Spectrophotometer, Shimadzu, model 1800.

2.3 Chemicals and reagents used
Ethanol obtained from local market, manufactured by Merck Pharmaceuticals.

2.4 Preparation of stock solution
The stock solution of salmeterol is prepared by dissolving 100 mg of drug in 100 ml methanol in volumetric flask with continuous shaking. 10 ml of sample was withdrawn and diluted to 100 ml methanol to get 10 μg/ml of solution. The solution was than scanned in UV range between 200-400 nm UV-VIS Spectrophotometer, Shimadzu, Japan to determine the absorption maxima of the drug against blank as ethanol.

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