Abstract
Lincomycin and spectinomycin combination therapy is widely used in veterinary medicine for the treatment of gastrointestinal and respiratory infections caused by lincomycin- and spectinomycin-sensitive microorganisms. A simple, reverse phase HPLC method for the analysis of samples of an injectable lincomycin and spectinomycin preparation containing a mixture of inactive excipients has been developed. The HPLC was carried out using the RP-C18 (250 mm × 4.0 mm, 5 μm) column, with the gradient mobile phase consisting of an acetonitrile and phosphate buffer at pH 6; the flow rate of 1 mL/min and ultraviolet detection at 220 nm. This method was validated in accordance with both FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity, and system suitability results within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations.
Highlights
IntroductionA formulation containing a combination of both lincomycin (a lincosamide-antibiotic derivative, produced by the microorganism Streptomyces lincolnensis) and spectinomycin (aminoglycoside-like antibiotic produced by Streptomyces spectabilis) is widely used in veterinary medicine for the treatment of gastrointestinal and respiratory infections caused by lincomycin and spectinomycin-sensitive micro-organisms, like Campylobacter, E. coli, Mycoplasma, Salmonella, Staphylococcus, Streptococcus, and Treponema sp. in a wide variety of animals including: calves, cats, dogs, goats, poultry, sheep, and turkeys [1,2,3,4]
A formulation containing a combination of both lincomycin and spectinomycin is widely used in veterinary medicine for the treatment of gastrointestinal and respiratory infections caused by lincomycin and spectinomycin-sensitive micro-organisms, like Campylobacter, E. coli, Mycoplasma, Salmonella, Staphylococcus, Streptococcus, and Treponema sp. in a wide variety of animals including: calves, cats, dogs, goats, poultry, sheep, and turkeys [1,2,3,4]
The only reported methods for the determination of the two agents in a formulation employs reverse phase liquid chromatography (RP-LC) coupled to a specialised Pulsed Amperometric Detector (PAD) utilising a gold electrode [11] or highly specialised bioanalytical methods [12,13,14,15], both of which are unsuitable for routine QA/QC applications
Summary
A formulation containing a combination of both lincomycin (a lincosamide-antibiotic derivative, produced by the microorganism Streptomyces lincolnensis) and spectinomycin (aminoglycoside-like antibiotic produced by Streptomyces spectabilis) is widely used in veterinary medicine for the treatment of gastrointestinal and respiratory infections caused by lincomycin and spectinomycin-sensitive micro-organisms, like Campylobacter, E. coli, Mycoplasma, Salmonella, Staphylococcus, Streptococcus, and Treponema sp. in a wide variety of animals including: calves, cats, dogs, goats, poultry, sheep, and turkeys [1,2,3,4]. This study reports the development and validation of a simple reverse phase chromatographic method using UV detection for the routine analysis and quality control of the combined spectinomycin and lincomycin injectable formulation which contains the active ingredients: lincomycin hydrochloride (LH, 50 mg/mL) and spectinomycin sulphate (SS, 100 mg/mL), and a mixture of inactive excipients manufactured by the Advanced Veterinary Company in Ramallah-Palestine. The advantage of this proposed protocol over previously reported methods is its simplicity and broad applicability using a standard HPLC system and UV detection. HPLC grade water was obtained through double distillation via Aquatron distillation equipment (Model A 4000D)
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