Quantitation of Cephalexin in Pharmaceutical Dosage Forms Using High-Performance Liquid Chromatography

A high-performance liquid chromatography method has been developed to quantify cephalexin in pharmaceutical dosage forms, capsules, pediatric drops and suspensions. The method is accurate and precise with a percent relative standard deviation of 0.8 based on 6 readings. There is no interference from a variety of excipients present in the dosage forms. The procedure for the extraction of cephalexin from the dosage forms is very simple. The method is stability indicating since a sample decomposed using sodium hydroxide showed very little potency and new peaks in the chromatogram. In the powder form cephalexin appears to be very stable.     

Quantitation of Cephalexin in Pharmaceutical Dosage Forms Using High-Performance Liquid Chromatography

Abstract

A high-performance liquid chromatography method has been developed to quantify cephalexin in pharmaceutical dosage forms, capsules, pediatric drops and suspensions. The method is accurate and precise with a percent relative standard deviation of 0.8 based on 6 readings. There is no interference from a variety of excipients present in the dosage forms. The procedure for the extraction of cephalexin from the dosage forms is very simple. The method is stability indicating since a sample decomposed using sodium hydroxide showed very little potency and new peaks in the chromatogram. In the powder form cephalexin appears to be very stable.     

Quantitation of Cefadroxil in Pharmaceutical Dosage Forms Using High-Performance Liquid Chromatography

A high-performance liquid chromatography method for the quantitation of cefadroxil has been developed. The method has been applied to quantify cefadroxil in pharmaceutical dosage forms (capsules, suspensions and tablets) of 2 different manufacturers. A simple extraction procedure to extract cefadroxil from the dosage forms has been developed. The results were excellent with percent relative standard deviation of 1.2 based on 5 readings. A variety of inactive ingredients present in the dosage forms did not interfere with the assay procedure. After formulating, the suspensions were stable for longer periods at 5^o than recommended on the label.     

Quantitation of Famotidine in Pharmaceutical Dosage Forms Using High-Performance Liquid Chromatography

Abstract

A stability-indicating high-performance liquid chromatography method for the quantitation of famotidine in injections, suspensions and tablets has been developed. The method is precise and accurate with a percent relative standard deviation of 1.1–1.3 based on 5 readings. The excipients present in the dosage forms did not interfere with the assay procedure. The recovery from the synthetic mixtures was quantitative. The samples decomposed under drastic conditions showed a total of 3 new peaks in the chromatograms     

Quantitation of Famotidine in Pharmaceutical Dosage Forms Using High-Performance Liquid Chromatography

A stability-indicating high-performance liquid chromatography method for the quantitation of famotidine in injections, suspensions and tablets has been developed. The method is precise and accurate with a percent relative standard deviation of 1.1-1.3 based on 5 readings. The excipients present in the dosage forms did not interfere with the assay procedure. The recovery from the synthetic mixtures was quantitative. The samples decomposed under drastic conditions showed a total of 3 new peaks in the chromatograms     

Quantitation of Ranitidine Hydrochloride in Tablets and Injections Using High-Performance Liquid Chromatography

Abstract

A stability-indicating reverse-phase high-performance liquid chromatography method without the use of a counterion has been developed to quantify ranitidine hydrochloride in pharmaceutical dosage forms. The method is accurate and precise with a percent relative standard deviation of 1.5 based on 5 injections. The extraction procedure for ranitidine from tablets is very simple and there was no interference from the excipients present. Ranitidine appears to be stable to heat on the acidic side and very susceptible to decomposition on the basic side. It lost 84.4% of potency on 20 minute boiling with sodium hydroxide with a new peak in the chromatogram. It lost 37.8% of the potency on treatment with hydrogen peroxide solution for 20 minutes at room temperature with 2 new peaks in the chromatogram.     

Quantitation of Ciprofloxacin Hydrochloride and Norfloxacin in Tablets Using High-Performance Liquid Chromatography

A stability-indicating high-performance liquid chromatography method for the quantitation of ciprofloxacin and norfloxacin in tablets (the only dosage form available at present) has been developed. The method is precise and accurate with a percent relative standard deviation based on 5 readings of 1.2 and 1.4 for ciprofloxacin and norfloxacin, respectively. A number of inactive ingredients present in the tablets did not interfere with the assay procedures. The addition of hydrochloric acid in the extraction procedure was necessary for the quantitative recovery and reproducible results. The recovery from the synthetic mixtures was quantitative. Both the drugs (quinolones) appear to be very stable since 10 minute boiling with either sulfuric acid or sodium hydroxide solution caused very little decomposition.     

Quantitation and Stability of Verapamil Hydrochloride using High-Performance Liquid Chromatography

Abstract

A high-performance liquid chromatography method for the quantitation of verapamil hydrochloride in pharmaceutical dosage forms has been developed. The method is precise and accurate with a relative standard deviation of 0.63% based on six injections. No preliminary extraction procedure is required to assay injections and a very simple extraction procedure is needed for tablets. There is no interference from the excipients and the method appears to be stability-indicating. The optimum pH range of stability is about 3.2 to 5.6 and the phosphate buffer and ionic strength have very little effect on the stability. Verapamil hydrochloride appears to be a very stable compound since in 105 days at 50°, the aqueous solutions (0.5 mg/ml) did not decompose.     

Quantitation and Stability of Verapamil Hydrochloride using High-Performance Liquid Chromatography

A high-performance liquid chromatography method for the quantitation of verapamil hydrochloride in pharmaceutical dosage forms has been developed. The method is precise and accurate with a relative standard deviation of 0.63% based on six injections. No preliminary extraction procedure is required to assay injections and a very simple extraction procedure is needed for tablets. There is no interference from the excipients and the method appears to be stability-indicating. The optimum pH range of stability is about 3.2 to 5.6 and the phosphate buffer and ionic strength have very little effect on the stability. Verapamil hydrochloride appears to be a very stable compound since in 105 days at 50°, the aqueous solutions (0.5 mg/ml) did not decompose.     

Quantitation of Acyclovir in Pharmaceutical Dosage forms using High-Performance Liquid Chromatography

A stability-indicating high performance liquid chromatography method for the quantitation of acyclovir in pharmaceutical dosage forms (capsules, ointment and injection) has been developed. The method is accurate and precise with a percent relative standard deviation of 1.2 based on 5 readings. The excipients present in the dosage forms did not interfere with the assay method. The recovery from the synthetic mixtures was quantitative. The samples decomposed under drastic conditions showed a new peak in the chromatogram. Acyclovir appears to be more stable in the alkaline than in the acidic solution. There appears to be a distribution/decomposition problem with the ointment sample being marketed in certain types of tubes used previously and still on the market.     

Quantitation of Acetaminophen, Chlorpheniramine Maleate, Phenyl Toloxamine Citrate and Pseudoephedrine Hydrochloride in Combination in Capsules and Tablets Using High-Performance Liquid Chromatography

A high-performance liquid chromatography method has been developed for the quantitation of acetaminophen, chlorpneniramine and pseudoephedrine in combination in capsules and tablets using a non-polar (μ/C18) column and 3 different mobile phases. A very simple preliminary extraction procedure is required before injecting onto the chromatograph. The method is accurate and precise with percent relative standard deviations based on 6 injections of 0.9, 1.9 and 1.1 for acetaminophen, chlorpneniramine and pseudoephedrine, respectively. Phenyltoloxamine citrate which is often mixed with acetaminophen has also been quantified using the developed method. The percent relative standard deviation based on 6 injections of phenyltoloxamine has been determined to be 1.0.     

Quantitation of Acyclovir in Pharmaceutical Dosage forms using High-Performance Liquid Chromatography

Abstract

A stability-indicating high performance liquid chromatography method for the quantitation of acyclovir in pharmaceutical dosage forms (capsules, ointment and injection) has been developed. The method is accurate and precise with a percent relative standard deviation of 1.2 based on 5 readings. The excipients present in the dosage forms did not interfere with the assay method. The recovery from the synthetic mixtures was quantitative. The samples decomposed under drastic conditions showed a new peak in the chromatogram. Acyclovir appears to be more stable in the alkaline than in the acidic solution. There appears to be a distribution/decomposition problem with the ointment sample being marketed in certain types of tubes used previously and still on the market.     

Quantitation of Propranolol Hydrochloride in Pharmaceutical Dosage Forms by High-Performance Liquid Chromatography

Abstract

A high-performance liquid-chromatography method for the quantitation of propranolol hydrochloride in pharmaceutical dosage forms (capsules, injections and tablets) has been developed. The method can also be used for contents uniformity as required by USP-NF. There is no interference from the excipients present and from hydrochlorothiazide which is often mixed with propranolol hydrochloride. The method is accurate, reproducible and precise with a percent relative standard deviation of 0.6 based on 5 readings. A sample decomposed with sodium hydroxide treatment showed about 9% potency and 2 new peaks in the chromatogram.     

Quantitation of Hydrochlorothiazide in Combination with Methyldopa and Propranolol Hydrochloride by High-Performance Liquid Chromatography

A stability indicating assay method based on highperformance liquid chromatography has been developed for the quantitation of hydrochlorothiazide in combination with methyldopa and propranolol hydrochloride. The method is accurate, reproducible and precise with an average percent relative standard deviation of 1.3. The method can also be used for the quantitation of the only known impurity/decomposition product (4-amino, 6 chloro, 1,3 benzenedisulfonamide) in hydrochlorothiazide. For the complete separation of methyldopa from hydrochlorothiazide, a counterion, 1-heptanesulfonic acid sodium was added to the mobile phase to increase the retention time of methyldopa. A 4-5 minutes time to extract hydrochlorothiazide from tablets appears to be satisfactory.     

Quantitation of Flurbiprofen in Tablets Using High Performance Liquid Chromatography

A stability-indicating high-performance liquid chromatography method for the quantitation of flurbiprofen in tablets was developed. The method is accurate and precise with a percent relative standard deviation of 0.7 based on 8 readings. A number of inactive ingredients present in the tablets did not interfere with the assay procedure. The extraction procedure from the tablets is very simple. The recovery from the synthetic mixtures was quantitative. The drug appears to be very sensitive to strong acids and bases since a 5 minute boiling caused the degradation of drug (100 %) in both the solutions     

Quantitation of Cefaclor in Pharmaceutical Dosage Forms Using High Performance Liquid Chromatography

A stability-indicating high-performance liquid chromatography for the quantitation of cefaclor in pharmaceutical dosage forms has been developed. The method is accurate and precise with a percent relative standard deviation of 1.2 based on 5 readings. A number of inactive ingredients present in the capsules and suspensions did not interfere with the assay procedure. The extraction procedure from the dosage forms is very simple. The recovery from the synthetic mixtures was quantitative. The capsules which had expired 3 years ago lost only 3% of the potency. The drug appears to be very sensitive to strong acids or bases since a 5 minute boiling caused 100% degradation of drug in both the solutions.     

Quantitation of Cefaclor in Pharmaceutical Dosage Forms Using High Performance Liquid Chromatography

Abstract

A stability-indicating high-performance liquid chromatography for the quantitation of cefaclor in pharmaceutical dosage forms has been developed. The method is accurate and precise with a percent relative standard deviation of 1.2 based on 5 readings. A number of inactive ingredients present in the capsules and suspensions did not interfere with the assay procedure. The extraction procedure from the dosage forms is very simple. The recovery from the synthetic mixtures was quantitative. The capsules which had expired 3 years ago lost only 3% of the potency. The drug appears to be very sensitive to strong acids or bases since a 5 minute boiling caused 100% degradation of drug in both the solutions.     

Quantitation of Sulfacetamide,Sulfadiazine, Sulfamerazine and Sulfame Thazine in Various Cominations Dsing High-Performance Liquid Chromatography

Abstract

A reverse phase high-performance liquid chromatography method for the quantitation of sulfacetamide, sulfadiazine, sulfamerazine, and sulfamethazine in various combinations has been developed. The method is simple, accurate, precise and reproducible. The percent relative standard deviations based on 6 injections were 2.1, 0.6, 1.9, and 1.6 for sulfacetamide, sulfadiazine, sulfamerazine, and sulfamethazine, respectively. The ratio of peak heights (drug/internal standard) wer closely related (r value 0.99 or better) to concentrations (± 20% of the standard solution concentrations). The results of synthetic mixtures showed quantitative recovery and method was successfully applied to commercial dosage forms (tablets and suspension). Extraction of sulfa drugs from the dosage forms required a very simple procedure.     

Quantitation of Sulfacetamide, Sulfadiazine, Sulfamerazine and Sulfame Thazine in Various Cominations Dsing High-Performance Liquid Chromatography

A reverse phase high-performance liquid chromatography method for the quantitation of sulfacetamide, sulfadiazine, sulfamerazine, and sulfamethazine in various combinations has been developed. The method is simple, accurate, precise and reproducible. The percent relative standard deviations based on 6 injections were 2.1, 0.6, 1.9, and 1.6 for sulfacetamide, sulfadiazine, sulfamerazine, and sulfamethazine, respectively. The ratio of peak heights (drug/internal standard) wer closely related (r value 0.99 or better) to concentrations (± 20% of the standard solution concentrations). The results of synthetic mixtures showed quantitative recovery and method was successfully applied to commercial dosage forms (tablets and suspension). Extraction of sulfa drugs from the dosage forms required a very simple procedure.     

Quantitation of Promethazine Hydrochloride in Pharmaceutical Dosage Forms Using High Performance Liquid Chromatography

A stability-indicating HPLC assay method has been developed to quantify promethazine hydrochloride in pharmaceutical dosage forms, injection, oral liquids, suppositories and tablets. The method is accurate and precise with a percent relative standard deviation of 0.4 based on 6 readings. The recoveries from the synthetic mixtures were quantitative. Three new peaks in the chromatogram were detected from a decomposed sample. A number of active and inactive ingredients, colors, preservatives, flavors, antioxidants, phenylephrine and codeine present in the dosage forms did not interfere with the assay procedure.