Entity

Time filter

Source Type


A simple, precise, shorter runtime and stability indicating reversephase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC) preservative in pharmaceutical formulation of sparfloxacin eye drop. The method was successfully applied for determination of benzalkonium chloride in various ophthalmic formulations like latanoprost, timolol, dexametasone, gatifloxacin, norfloxacin, combination of moxifloxacin and dexamethasone, combination of nepthazoline HCl, zinc sulphate and chlorpheniramine maleate, combination of tobaramycin and dexamethasone, combination of phenylephrine HCl, naphazoline HCl, menthol and camphor. The RP-LC separation was achieved on an Purospher Star RP-18e 75 mm × 4.0 mm, 3.0 μ in the isocratic mode using buffer: acetonitrile (35: 65, v/v), as the mobile phase at a flow rate of 1.8 mL/min. The methods were performed at 215 nm; in LC method, quantification was achieved with PDA detection over the concentration range of 50 to 150 μg/mL. The method is effective to separate four homologs with good resolution in presence of excipients, sparfloxacin and degradable compound due to sparfloxacin and BKC within five minutes. The method was validated and the results were compared statistically. They were found to be simple, accurate, precise and specific. The proposed method was validated in terms of specificity, precision, recovery, solution stability, linearity and range. All the validation parameters were within the acceptance range and concordant to ICH guidelines. Source


Lashkari P.D.,MTS India | Mody V.,Cadila Pharmaceutical Ltd
International Journal of ChemTech Research | Year: 2010

Plants have been used for the treatment of diseases all over the world before the advent of modern clinical drugs and are known to contain substances that can be used for therapeutic purposes or as precursors for the synthesis of useful drugs. Thus over 50% of these modern drugs are of natural products origin and as such these natural products play an important role in drug development in the pharmaceutical industry. The sensitivity towards the microorganism was increased as concentration is increases. Arowash liquid has (30 - 80 μl) maximum sensitivity towards Staphylococcus aureus while it has low sensitivity towards the Bacillus subtilis. Arowash liquid has similar effect with the standard drug (Nitrofurazone). Source


Trivedi H.K.,Cadila Pharmaceutical Ltd | Patel M.C.,P.A. College
International Journal of ChemTech Research | Year: 2010

A simple reversed-phase high performance liquid chromatography has been developed and employed for the analysis of Omeprazole and its related substances in bulk material and commercial dosage forms. A gradient elution of filtered sample was performed on Zorbax XDB C8 (150 x 4.6), 5μ column with Glacine buffer (pH -8.8) as a mobile phase-A, Acetonitrile: Methanol (83:17) as a mobile phase-B and UV detection at 302 nm. Mobile phase was delivered at flow of 1.2 mL/min and at maintaining the column temperature at 25oC, quantification was achieved with reference to the external standards. The active ingredient-omeprazole was successfully separated from its all related substances, including process impurities and other possible impurities of oxidation and decomposition. The excipients did not interfere with the determination of omeprazole and its related compound in commercial dosage formulations. The method was rapid, simple, accurate and reproducible. It was not only successfully employed for the assay of omeprazole in bulk material and pharmaceutical dosage forms but also for the determination of its related substances. A statistical design of experiments was used for the robustness evaluation of HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use. Source


Trivedi H.K.,Cadila Pharmaceutical Ltd | Patel M.C.,P.A. College
International Journal of ChemTech Research | Year: 2010

A simple, short, rapid, sensitive and robust reversed phase-HPLC method was developed and validated to measure the amount of Azithromycin in dissolution profile. An isocratic elution of filtered sample was performed on cosmosil RP18 (50mm x 4.6mm), 5μm column with phosphate buffer (pH 7.5) & methanol (35:65 v/v) as mobile phase and UV detection at 210 nm. Mobile phase was delivered at flow of 2.0mL/min and maintaining the column temperature at 50°C and quantification was achieved with reference to the external standards. The total run time is about three minutes only. The Azithromycin and two degradable impurities are separated with good resolution within three minutes. The linearity for concentrations between 70μg/mL and 840μg/mL (12.5% to 150.0%) for Azithromycin was established. The percentage RSD during intra and inter-day precision was about 2.4 & 3.7% which is less than 6.0%. The method was successfully applied for the determination of Azithromycin in a pharmaceutical formulation without any interference from common excipients, diluent and dissolution medium. In addition, standard and sample solutions stability and robustness were demonstrated. A statistical design of experiments was used for the robustness evaluation of HPLC method. All results were accepted and confirmed that the method is suitable for its intended applications. All the validation parameters were within the acceptance range, and concordant to ICH guidelines. Source


Mehta J.,Cadila Pharmaceutical Ltd | Patidar K.,Cadila Pharmaceutical Ltd | Vyas N.,Cadila Pharmaceutical Ltd
E-Journal of Chemistry | Year: 2010

A simple and precise reversed phase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC) preservative in pharmaceutical formulation of latanoprost eye drops. The analyte was chromatographed on a Waters Spherisorb CN, (4.6x250 mm) column packed with particles of 5 μm. The mobile phase, optimized through an experimental design, was a 40:60 (v/v) mixture of potassium dihydrogen orthophosphate buffer (pH 5.5) and acetonitrile, pumped at a flow rate of 1.0 mL/min at maintaining column temperature at 30 oC. Maximum UV detection was achieved at 210 nm. The method was validated in terms of linearity, repeatability, intermediate precision and method accuracy. The method was shown to be robust, resisting to small deliberate changes in pH, flow rate and composition (organic ratio) of the mobile phase. The method was successfully applied for the determination of BKC in a pharmaceutical formulation of latanoprost ophthalmic solution without any interference from common excipients and drug substance. All the validation parameters were within the acceptance range, concordant to ICH guidelines. Source

Discover hidden collaborations