Liquid dosage forms analysis

Liquid Dosage Forms. Simple aqueous solutions, symps, elixirs, and tinctures are prepared by dissolution of solutes in the appropriate solvent systems. Adjunct formulation ingredients include certified dyes, flavors, sweeteners, and antimicrobial preservatives. These solutions are filtered under pressure, often using selected filtering aid materials. The products are stored in large tanks, ready for filling into containers. QuaUty control analysis is then performed. 

The first published analysis for powders was written in 1981 by Becconsall et al. It described the analysis of propranolol and magnesium carbonate mixes. In 1987, Ciurczak and Torlini published on the analysis of solid and liquid dosage forms using reflectance and transflectance, respectively. 

Ciurczak, E.W. Torlini, R.P. Analysis of solid and liquid dosage forms using near-infrared reflectance spectroscopy. Spectrosc. 1987, 2 (3), 41 3. 

Pharmaceutical liquids require very minimal sample preparation they can be injected directly, diluted in mobile phase or other suitable diluent, or extracted into an organic solvent. A diluent is chosen to maintain solubility of the analyte as well as compatibility with the chromatographic system. Pharmaceutical suspensions must be pretreated to dissolve the drug prior to analysis. Another liquid dosage form is an emulsion, in which the liquid is suspended in a second immiscible liquid such as polydimethylsilicone. The sample preparation must break the emulsion. In the analysis of a polydimethylsilicone suspension, a liquid-liquid extraction is generally used to break the emulsion and prepare the sample for simethicone measurement. 

E. W. Ciurczak, Analysis of Solid and Liquid Dosage Forms via NIRS, presented at FACSS, Philadelphia, October 1985. 

J. C. Chasseur, Analysis of Sohd and Liquid Dosage Forms via NIRS, Chim. Oggi, 6,21 19S7). 

The following year, Ciurczak and Torlini [30] published a paper on the analysis of solid and liquid dosage forms by NIR. The authors contrasted the use of NIR in the development of calibrations for natural products with that for pharmaceutical dosage forms. They noted that natural products require the development of a reference method for calibration development, while pharmaceutical dosage forms could be synthetically prepared to develop a calibration. 

In the study by Ciurczak and Torlini, the performance of NIR was compared with high performance liquid chromatography (HPLC) for speed and accuracy of results in dosage form analysis. The effect of milling the samples prior to analysis was also investigated. Two solid dosage form matrices. 

Sidhu et al [86] developed a reliable and simple high performance liquid chromatographic method for the routine analysis of pharmaceutical dosage forms using a Cig Bondapak reversed-phase column with a binary solvent system consisting of... 

Sephadex G-25 buffered at alkaline pH s has been found to possess excellent resolving power in some cases (144, 145, 146). A column liquid chromatographic method for determining TC in various dosage forms was automated. Each chromatogram consisted of a continuous flow separation of components followed by a spectral determination of the column eluate at a rate of 12 samples per hour (147). Gel chromatography has also been applied to the analysis of TC antibiotics using a Bio-Gel P-2 column with 0.1M acetic acid as an eluent (148). 

J. E. Kountourellis and C. K. Markopoulou, A simultaneous analysis by HPLC of bamipine combined with tricyclic antidepressants and/or antipsychotics in dosage forms, J. Liquid Chromatogr., 14 2969 (1991). 

L. Elrod, D. M. Shada, and V. E. Taylor, High-performance liquid chromatographic analysis of clorazepate dipotassium and monopotassium in solid dosage forms, J. Pharm. Sci., 70 793 (1981). 

A. S. Sidhu, J. M. Kennedy, and S. Deeble, General method for the analysis of pharmaceutical dosage forms by high-performance liquid chromatography, J. Chromatogr., 391 233 (1987). 

H. N. Al-Kaysi and N. A. Sheikh Salem, High pressure liquid chromatographic analysis of orphenadrine citrate and acetaminophen in pharmaceutical dosage forms, Anal. Lett., 20 1451 (1987). 

Ozkan Y, Yilmaz N, Ozkan SA, Birvol I. 2000. High-performance liquid chromatographic analysis of verapamil and its application to determination in tablet dosage forms and to drug dissolution studies. Farmaco 55(5) 376-382. 

Panderi and Parissi-Poulou developed a microbore liquid chromatographic method for the simultaneous determination of benazepril hydrochloride and hydrochlorothiazide in pharmaceutical dosage forms [30]. The use of a BDS C-18 microbore analytical column was found to result in substantial reduction in solvent consumption and in increased sensitivity. The mobile phase consisted of a mixture of 25 mM sodium dihydrogen phosphate buffer (pH 4.8) and acetonitrile (11 9 v/v), pumped at a flow rate of 0.4 mL/min. Detection was effected at 250 nm using an ultraviolet absorbance detector. The intra- and inter-day relative standard deviation values were less than 1.25% (n = 5), while the relative percentage error was less than 0.9% (n = 5). The detection limits obtained according to the IUPAC definition were 0.88 and 0.58 pg/mL for benazepril hydrochloride and hydrochlorothiazide, respectively. The method was applied to the quality control of commercial tablets and content uniformity test, and proved to be suitable for rapid and reliable analysis. 

High-performance liquid chromatography (HPLC) has been used to analyze metronidazole [1435-1437], misonidazole [1309,1438], and other nitroimidazoles [1435, 1439] in body fluids or pharmaceutical dosage forms. HPLC analysis of effect of hypoxic-cell radiosensitizer misonidazole on the radiation-induced reduction of DNA bases (thymine, cytosine, and adenine) has been carried out [1440, 1441], HPLC was employed to characterize different nitroimidazoles [327, 366, 388,409, 450, 1442-1444], nitropyrazoles [246, 301], nitrothiazoles [366], l-aryl(hetaryl)-4-nitro-l,2,3-triazoles [601], nitrobenzimidazoles [707], nitrobenzofurazans [774, 1445-1449], nitrobenzotriazoles [1450],... 

Patil et al. [46] developed a simple, rapid, and precise stability-indicating liquid chromatographic method for analysis of lornoxicam in pharmaceutical dosage forms. Chromatographic separation of drug and its degradation products was achieved on a Cig analytical column with... 

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