Light Straw Colored Liquid

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Propofol (PROP): PROP is a sedative hypnotic agent used for the induction and maintenance of anesthesia or sedation. It is a short acting medication that results in a decreased level of consciousness and lack of memory for events. Its uses include the starting and maintenance of general anesthesia, sedation for mechanically ventilated adults and procedural sedation. Intravenous injection of a therapeutic dose of PROP produces hypnosis rapidly with minimal excitation usually within 40 seconds from the start of an injection. 27-30

The common side effects include difficulty in breathing, swelling of face, lips, tongue or throat, nausea, slight burning sensation at the site of injection.

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Some of the serious side effects include seizures (convulsion), weak or shallow breathing, fast and slow heart rate, pain, swelling, blisters or skin changes where the medicine was injected.31 The mechanism of action of PROP involves a positive modulation of the inhibitory function of the neurotransmitter gamma - amino butyric acid (GABA) through GABAA receptors. PROP analogues have shown that they also acts as sodium channel blockers.

32-34

Upon literature survey it was found that few methods have been reported for the estimation of PROP in biological samples using methods such as GC, HPLC and capillary gas chromatographic methods.35-37 Pharmacokinetic and pharmacodynamic studies have been reported on this drug with the aid of HPLC , GC and Mass spectroscopy and few spectrophotometric methods in comparison with flourimetric detections have been reported.38-48 But so far no single method was found for the estimation of PROP in pharmaceutical formulations or in bulk drug.

In view of the need for a suitable methods for routine analysis of PROP in bulk and in its formulations, attempts are being made to develop simple, precise and accurate analytical methods for the estimation of PROP and extend it for their determination in formulations.

METHODOLOGY

UV-VISIBLE SPECTROPHOTOMETERIC METHODS.

Method A: Zero Order Absorption
Method B: First Order Derivative
Method C: Area Under Curve

HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD.

Method D: Reverse Phase High Performance Liquid Chromatography

Chemical reagents and Drug sample: Methanol of AR grade, procured from E-Merck ltd, Mumbai, India was used as the solvent. Standard Propofol was obtained as a gift sample from Amneal Pharmaceuticals, Ahmadabad, Gujarat. The drug is certified to contain 99.7% purity and it is used without further purification. Diprivan an intravenous anesthetic injection, batch number 205624 of Abbott company claimed to contain 10 mg/mL was used in the analysis.

METHOD A: ZERO ORDER ABSORPTION METHOD.

Selection of wavelength for analysis and preparation of standard calibration curves.

Preparation of standard stock solution:

100 mg of PROP was weighed and transferred in to 100 mL volumetric flask. The drug was dissolved in 50 mL of methanol by sonication and then volume was made up to the mark with methanol to obtain a concentration of 1000 µg/mL (stock A solution). From stock A solution 10 mL of aliquot was pipetted out in a 100 mL volumetric flask and the volume was made up to the mark with methanol to obtain a concentration of 100 µg/mL (stock B solution).

Selection of analytical wavelength and analytical concentration range:

From the standard stock B solution, dilutions ranging between 10 to 90 µg/mL were prepared and scanned in the wavelength range of 400-200 nm using UV Spectrophotometer. At 272 nm PROP showed maximum absorbance. Hence 272 nm was selected as the working analytical wavelength. The drug obeyed the Beer's law in the concentration range of 10 to 50 µg/mL.

Preparation of calibration curve for PROP:

Appropriate aliquots were pipetted out from the standard stock B solution in to a series of 10 mL volumetric flasks. The volume was made up to the mark with methanol to obtain a set of solutions having the concentration of 10, 20, 30, 40 and 50 µg/mL of PROP. Absorbance of the above solution was measured at 272 nm and a calibration curve of absorbance against concentration was plotted. The plot is represented in fig: 2.1(c) and the absorbance values of each concentration are represented in table no. 2.1(a).