Abstract
HPLC stability-indicating method has been developed for the simultaneous determination of Butamirate citrate and Benzoic acid in pharmaceutical dosage forms. Active compounds were separated on Zorbax SB-C8 column (250 mm × 4.6 mm, 5 μm Agilent) at an ambient temperature. Elution was performed with a mobile phase consisting of acetonitrile (solvent A) and a mixture of 10 gm of sodium lauryl sulphate and 5ml of 1 N sulphuric acid in 1000 ml distilled water (solvent B) at a ratio of 70:30 v/v and a flow-rate of 1.7 ml/min. Detection was performed with UV detector at 205 nm. Cough syrup preparation was subjected to long-term stability in order to demonstrate that storage conditions and degradants from both active compounds did not interfere with the quantification of Butamirate citrate and Benzoic acid. Typical validation characteristics such as linearity, range, precision, accuracy, and selectivity were evaluated for Butamirate citrate and Benzoic acid. Using the novel method, both Butamirate citrate and Benzoic acid were separated successfully. Validation studies demonstrated that the novel method possessed a linear UV response, good system precision and accuracy, high sensitivity and specificity for Butamirate citrate and Benzoic acid.
Highlights
Stability testing of pharmaceutical products provides necessary information about the effect of different environmental factors such as temperature, humidity and light on the quality of the finished product, and helps in the determination of the shelf-life as well as the optimal storage and usage conditions [1,2]
The drug is mainly prescribed in the form of a syrup containing benzoic acid (Figure 1B) acting as a preservative in order to protect against any microbial growth
As there is no method reported in the literature for the simultaneous determination of both butamirate citrate and benzoic acid in cough preparations, it was considered useful to develop and validate a sensitive spectrophotometric method associated with high performance liquid chromatography
Summary
Stability testing of pharmaceutical products provides necessary information about the effect of different environmental factors such as temperature, humidity and light on the quality of the finished product, and helps in the determination of the shelf-life as well as the optimal storage and usage conditions [1,2] It is essential for the analytical procedures used in stability testing of pharmaceutical products to be validated and stability-indicating [1,2]. There are only few previous studies reporting a method for the determination of butamirate citrate in cough preparations Those studies mainly focused on the determination of relative bioavailability of the drug after single oral administration [7], the determination of the compound using an optical compensation method [8] or by using derivative spectrophotometric procedures [5]. As there is no method reported in the literature for the simultaneous determination of both butamirate citrate and benzoic acid in cough preparations, it was considered useful to develop and validate a sensitive spectrophotometric method associated with high performance liquid chromatography
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