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DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS DETERMINATION OF MONTELUKAST SODIUM AND BAMBUTEROL HYDROCHLORIDE IN TABLETS  [PDF]
S. A. PATEL
International Journal of Pharmaceutical and Biological Research , 2011,
Abstract: The present manuscript describe simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of montelukast sodium and bambuterol hydrochloride in combined tablet dosage form. The method is based on the simultaneous equations for analysis of both the drugs using chloroform as solvent. Montelukast sodium has absorbance maxima at 345 nm and bambuterol hydrochloride has absorbance maxima at 266.5 nm in chloroform. The linearity was obtained in the concentration range of 5-40 μg/ml and 10-80 μg/ml for montelukast sodium and bambuterol hydrochloride, respectively. The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The mean recovery was 99.63 ± 0.47 and 99.57 ± 0.36 for montelukast sodium and bambuterol hydrochloride, respectively. The method was found to besimple, sensitive, accurate and precise and was applicable for the simultaneous determination of montelukast sodium and bambuterol hydrochloride in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies.
Determination of montelukast sodium and bambuterol hydrochloride in tablets using RP HPLC  [cached]
Patil Smita,Pore Y,Kuchekar B,Mane Aruna
Indian Journal of Pharmaceutical Sciences , 2009,
Abstract: An accurate, specific and precise assay level gradient reverse-phase high-performance liquid chromatographic method was developed for simultaneous determination of montelukast sodium and bambuterol hydrochloride in tablet dosage form. An inertsil ODS C-18, 5 μm column having 250x4.6 mm I.D. in gradient mode, with mobile phase A, containing 0.025 M sodium phosphate buffer: methanol (85:15) and mobile phase B, containing acetonitrile:methanol (85:15) was used at different time intervals. The flow rate was 1.5 ml/min and effluent was monitored at 218 nm. The retention times of montelukast sodium and bambuterol hydrochloride were 21.2 min and 5.8 min respectively. The linearity for both the drugs was in the range of 0.25-0.75 mg/ml with correlation coefficients of 0.9999 and 0.9996 for montelukast sodium and bambuterol hydrochloride, respectively.
SIMULTANEOUS DETERMINATION OF MONTELUKAST SODIUM AND BAMBUTEROL HYDROCHLORIDE IN TABLET DOSAGE FORM BY ULTRAVIOLET SPECTROPHOTOMETRY (DUAL WAVELENGTH METHOD)  [PDF]
D.J.Patel,,S.A.Patel,,S.K. Patel
International Journal of Pharmaceutical and Biological Research , 2010,
Abstract: A simple, accurate, and precise dual wavelength spectrophotometric method was developed for simultaneous determination of Montelukast sodium (MTKT) and Bambuterol hydrochloride (BAM) in combined pharmaceutical dosage forms. The principle for dual wavelength method is “the absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The method based on determination of MTKT at 322.0 nm using its absorptivity value and BAM at 266.0 nm after deduction of absorbance due to MTKT. The two drugs follow eer-Lambert’s law over the concentration range of 10-80 μg/mL for MTKT and 40-240 μg/mL for BAM. The % estimation of the drugs was found near to 100 % representing the accuracy of the three methods. The recovery of the MTKT and BAM were found near to 100 %. Validation of the proposed methods was carried out for its accuracy, precision, specificity and ruggedness according to ICH guidelines. The proposed methods can be successfully applied in routine work for the determination of MTKT and BAM in combined dosage form.
Spectrophotometric estimation of ropinirole hydrochloride in tablets  [cached]
Shete Yogita,Pimpodkar Nayana,Nalawade R,Pore Y
Indian Journal of Pharmaceutical Sciences , 2009,
Abstract: A simple, sensitive, rapid, accurate and precise spectrophotometric method has been developed for estimation of ropinirole hydrochloride in bulk and tablet dosage forms. Ropinirole hydrochloride shows maximum absorbance at 250 nm with molar absorptivity of 8.703x10 3 l/mol.cm. Beer′s law was obeyed in the concentration range of 5-35 μg/ml. Results of analysis were validated statistically and by recovery studies.
Spectrophotometric estimation of ambroxol hydrochloride and cetirizine hydrochloride in tablets  [cached]
Bhatia Neela,Ganbavale Santosh,More Harinath
Asian Journal of Pharmaceutics , 2008,
Abstract: A simple, rapid, accurate, precise and reproducible simultaneous equation method has been developed for simultaneous estimation of ambroxol hydrochloride and cetirizine hydrochloride in tablets. Ambroxol hydrochloride has absorbance maxima at 243 nm, while cetirizine hydrochloride has absorbance maxima at 229 nm in glass-distilled water. The method developed involves no separation or extraction process. The proposed methods were successfully applied to the determination of ambroxol hydrochloride and cetirizine hydrochloride in tablets, with high percentage of recovery, good accuracy, and acceptable precision. Different analytical performance parameters such as linearity, precision, accuracy, limit of detection, limit of quantitation, and robustness were determined according to International Conference on Harmonization ICH Q2B guidelines. Results of analysis of formulation given as percentage of label claim ± relative standard deviation were found to be 99.27 ± 0.8083 and 102.43 ± 1.5357 for ambroxol hydrochloride and cetirizine hydrochloride respectively. Results of recovery studies given as percentage of label claim ± relative standard deviation were found to be 99.88 ± 0.3811 and 100.36 ± 2.0480 for ambroxol hydrochloride and cetirizine hydrochloride respectively.
Visible spectrophotometric methods for the estimation of metoclopramide hydrochloride in tablets  [cached]
Patel S,Patel C,Patel M
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: Two simple, sensitive, accurate, and rapid visible spectrophotometric methods have been developed for the estimation of metoclopramide hydrochloride in tablets. Method A is based on the reaction of drug with 4-dimethyl amino-benzaldehyde (Ehrlich reagent) to yield a yellow colour Schiff′s base, which shows maximum absorbance at 438 nm against reagent blank, while method B is based on diazotisation of primary amine group of metoclopramide hydrochloride with sodium nitrite and hydrochloric acid followed by coupling with β-napthol (in alkaline medium) to form a red colour dye, which shows maximum absorbance at 553 nm against reagent blank. Beer′s law was obeyed in the concentration range of 10-100 μg/ml in method A and 1-10 μg/ml in method B. Results of the analysis were validated statistically and by recovery studies.
New spectrophotometric determination of Raloxifene hydrochloride in tablets  [cached]
Pavithra D,Sivasubramanian Lakshmi
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: Three new simple and sensitive spectrophotometric methods in UV/Vis region have been developed for the determination of raloxifene hydrochloride in bulk drug and in tablet formulations. Raloxifene hydrochloride exhibited maximum absorbance at 289 nm in methanol (method A) with apparent molar absorptivity of 3.67x104 l/mol.cm and maximum absorbance at 303 nm in 0.1 M sodium hydroxide with apparent molar absorptivity of 3.60x104 l/mol.cm (method B). Third method is based on the formation of red coloured chromogen with ferric nitrate and 1,10-phenanthroline, which showed maximum absorbance at 511 nm with apparent molar absorptivity of 1.06x105 l/mol.cm. Beer′s law was obeyed in the concentration range of 5-25 g/ml for method A and B and in the range of 2-10 μg/ml for method C. Results of all methods were validated statistically and by recovery studies.
Simultaneous spectrophotometric estimation of imipramine hydrochloride and chlordiazepoxide in tablets  [cached]
Patel Sejal,Patel N,Patel S
Indian Journal of Pharmaceutical Sciences , 2009,
Abstract: A binary mixture of imipramine HCl and chlordiazepoxide was determined by three different spectrophotometric methods. The first method involved determination of imipramine HCl and chlordiazepoxide using the simultaneous equations and the second method involved absorbance ratio method. Imipramine has absorbance maxima at 251 nm, chlordiazepoxide has absorbance maxima at 264.5 nm and isoabsorptive point is at 220 nm in methanol. Linearity was obtained in the concentration ranges of 1-25 and 1-10 μg/ml for Imipramine HCL and Chlordiazepoxide, respectively. The third method involved determination of these two drugs using the first-derivative spectrophotometric technique at 219 and 231.5 nm over the concentration ranges of 1-20 and 2-24 μg/ml with mean accuracies 99.46±0.78 and 101.43±1.20%, respectively. These methods were successively applied to pharmaceutical formulations because no interferences from the tablet excipients were found. The suitability of these methods for the quantitative determination of the compounds was proved by validation.
Rapid determination of Ziprasidone and Buclizine Hydrochloride in pharmaceutical formulations (Tablets) by simple spectrophotometric method  [PDF]
Medikondu Kishorea,Y.Hanumantha Rao,M.Janardhan
International Journal of Pharma Sciences and Research , 2010,
Abstract: A simple, sensitive, selective and accurate spectrophotometric method for the determination of Ziprasidone (ZPD) hydrochloride and Buclizine (BUCZ) hydrochloride in bulk drug and pharmaceutical formulations (tablets) has been described. This method is based on the formation of ion-association complex of drug with Alizarin red S (ARS) to form pale pink colored chromogen exhibiting max 420 nm respectively. The results of analysis for this method have been alidated statistically and by recovery studies. The results arecompared with those obtained using UV spectrophotometric method in isopropyl alcohol at 229 nm (ZPD), and in Chloroform at 272 nm (BUCZ). The method is simple and sensitive and has been applied successfully to the analysis of laboratory-made tablets without any interference from the tablet excipients.
Spectrophotometric and HPLC methods for simultaneous estimation of pseudoephedrine hydrochloride and loratadine from tablets  [cached]
Singhvi I,Bhatia Neela
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: Two simple, accurate, economical and reproducible UV spectrophotometric and one HPLC method for simultaneous estimation of two-component drug mixture of pseudoephedrine hydrochloride and loratadine in combined tablet dosage form have been developed. The first developed method employs multiwavelength spectroscopy using seven mixed standards and 257.0 nm and 283.0 nm as two wavelengths for estimation. The second method involves first derivative spectroscopy using 308.6 nm and 263.0 nm as zero crossing points for pseudoephedrine hydrochloride and loratadine respectively. For both spectrophotometric methods, 0.2 M hydrochloric acid was used as solvent. Linearity was observed in concentration range of 0-40 mg/ml of loratadine and 0-800 mg/ml of pseudoephedrine hydrochloride. Developed HPLC method is reverse-phase chromatographic method using Inertsil C 18 column and methanol:ammonium acetate buffer in ratio of 80:20 pH 7.5 as mobile phase. Nimesulide was used as internal standard for HPLC method. For HPLC method, linearity was observed in concentration range of 0-200 mg/ml of loratadine and 100-2000 mg/ml of pseudoephedrine hydrochloride. Results of analysis were validated statistically and by recovery studies.
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