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DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS DETERMINATION OF PROPRANOLOL HYDROCHLORIDE AND FLUNARIZINE DIHYDROCHLORIDE IN THEIR COMBINED DOSAGE FORMULATION  [PDF]
A.K. Doshi*, B.N. Patel and C.N. Patel
International Journal of Pharmaceutical Sciences and Research , 2012,
Abstract: A simple, accurate and precise spectrophotometric method has been developed for simultaneous estimation of Propranolol hydrochloride and Flunarizine dihydrochloride in combined dosage form. Simultaneous equation method is employed for simultaneous determination of Propranolol hydrochloride and Flunarizine dihydrochloride from combined dosage forms. In this method, the absorbance was measured at 289 nm for Propranolol hydrochloride and 253 nm for Flunarizine dihydrochloride. Linearity was observed in range of 24-64 μg/ml and 6-16 μg/ml for Propranolol hydrochloride and Flunarizine dihydrochloride respectively. Recovery studies confirmed the accuracy of proposed method and results were validated as per ICH guidelines. The method can be used for routine quality control of pharmaceutical formulation containing Propranolol hydrochloride and Flunarizine dihydrochloride.
Development and Validation of HPTLC Method for Estimation of Propranolol Hydrochloride and Flunarizine Dihydrochloride in Combined Dosage Form  [PDF]
Palak Patel,Kashyap K. Bhatt
ISRN Analytical Chemistry , 2012, DOI: 10.5402/2012/502604
Abstract: A simple, sensitive, and precise high-performance thin layer chromatographic method has been developed for the estimation of propranolol hydrochloride and Flunarizine dihydrochloride in combined dosage form. The method employed HPTLC aluminum plates precoated with silica gel 60F as the stationary phase while the solvent system was toluene:methanol: ethyl acetate: acetic acid (7?:?1.5?:?1.5?:?0.1 v/v/v/v). The Rf value was observed to be 0 . 0 7 ± 0 . 0 2 and 0 . 6 7 ± 0 . 0 2 for propranolol hydrochloride and flunarizine dihydrochloride. The densitometric analysis was carried out in absorbance mode at 240?nm. The method was linear in the range of 400–2400?ng/band for propranolol hydrochloride and 50–300?ng/band for flunarizine dihydrochloride. The method was validated with respected accuracy, precision and specificity. The limit of detection for Propranolol hydrochloride and flunarizine dihydrochloride were found to be 118.4 and 13.75?ng/spot, respectively. The limit of quantification for propranolol hydrochloride and flunarizine dihydrochloride was found to be 355.2 and 45.4?ng/band, respectively. The method was successfully applied to the estimation of propranolol hydrochloride and flunarizine dihydrochloride in combined dosage form. 1. Introduction Propranolol hydrochloride (PRO) is chemically, (RS)-2-(4-(2-methylpropyl) phenyl) 2-Propanol, 1-[(1-methylethyl) amino]-3-(1-naphthalenyloxy), hydrochloride. The empirical formula of PRO is C16H21NO2·HCl and has a molecular weight of 295.80?g/mole (Figure 1). It is antihypertensive agent used in hypertension [1]. Flunarizine dihydrochloride (FLU) is chemically 1-(bis(4-fluorophenyl)methyl)-4-(3-phenyl-2 propenyl)piperazine [2, 3]. It has an empirical formula C26H26F2N2 and a molecular weight of 404.495?g/mole (Figure 2). It is a calcium-blocking agent [1]. The combination dosage form of propranolol hydrochloride and Flunarizine dihydrochloride is available in the market, and it is indicated in the treatment of hypertension. Figure 1: Structure of Propranolol hydrochloride. Figure 2: Structure of flunarizine dihydrochloride. Propranolol hydrochloride is official in Indian Pharmacopoeia and British Pharmacopoeia. A literature survey regarding quantitative analysis of these drugs propranolol hydrochloride and flunarizine dihydrochloride revealed that attempts have been made to develop analytical methods for the estimation of alone and in combination with other drugs by liquid chromatographic (LC) [4–8], fluorometry [9], and spectrophotometric methods [10]. Flunarizine dihydrocholride is official in United
Spectrophotometric estimation of Lomefloxacin hydrochloride in pharmaceutical dosage form  [cached]
Suhagia B,Shah S,Rathod I,Patel H
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: A simple and sensitive spectrophotometric method has been developed for the estimation of lomefloxacin hydrochloride in its marketed formulations. The method is based on the reaction between the drug and the dichlone, in the presence of crotonaldehyde in dimethylsulfoxide, which produces a blue chromogen with absorption maximum at 645 nm. The good agreement with Beer′s law was found in the concentration range of 5-100 μg/ml. The optimum reaction conditions and other analytical parameters are evaluated. Statistical comparison of the results with those of reported method shows good agreement, and indicated no significant difference in precision. The proposed method was found to be simple, accurate, and reproducible for the routine analysis of the drug in pharmaceutical dosage forms.
Spectrophotometric method development and validation of itopride hydrochloride in bulk and dosage form  [cached]
Santosh U. Zate,Paresh I. Kothawade,Jitendra W Gajbe,Anantwar S. Pramod
International Journal of Drug Delivery , 2011,
Abstract: A simple, precise and economical spectrophotometric method for the estimation of Itopride hydrochloride in pharmaceutical bulk and tablet dosage form was developed and validated. Identification was carried out using a UV-visible double beam spectrophotometer detector with working wavelength at 258nm in 0.1N HCl medium. The method was validated with respect to its specificity, linearity range, accuracy, and precision in analytical media. Itopride hydrochloride show the maximum absorbance (λmax) at 258 nm, Regression analysis showed good correlation in the concentration range 5-100 mcg/ml and 96.80 to 106.84% recovery with relative standard deviation 0.293 to 3.98%. Statistical treatment of data reflects that the proposed method is precise, accurate and easily applicable for determination of Itopride hydrochloride in bulk and pharmaceutical preparation. Keywords: Spectrophotometric; Itopride hydrochloride; Validation.
Spectrophotometric estimation of pioglitazone hydrochloride in tablet dosage form  [cached]
Basniwal Pawan,Srivastava Prabhat,Jain Deepti
Asian Journal of Pharmaceutics , 2008,
Abstract: Two simple, rapid, and precise methods - linear regression equation (LRE) and standard absorptivity - were developed and validated for the estimation of pioglitazone hydrochloride in tablet dosage form. The maximum absorbance (lmax ) of pioglitazone hydrochloride was found to be 269.8 nm in methanol:water:hydrochloric acid (250:250:1). Beer-Lambert law was obeyed in the concentration range of 10-50 μg/ml, and the standard absorptivity was found to be 253.97 dl/g/cm. Both the methods were validated for linearity, accuracy, precision (days, analysts, and instrument variation), and robustness (solvent composition). The numerical values for all parameters lie within the acceptable limits. Pioglitazone hydrochloride was estimated in the range of 99.58-99.97% by LRE method and 100.25-100.75% by standard absorptivity method. At 99% confidence limit, the F-test value for the methods was found to be 1.8767.
SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN TABLET DOSAGE FORM  [PDF]
Ghodasara Rahul B,Prajapati Arun M
International Research Journal of Pharmacy , 2013,
Abstract: The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of ambroxol hydrochloride, levocetirizine dihydrochloride and phenylephrine hydrochloride in bulk and tablet dosage form. The method is based on the simultaneous equations for analysis of the three drugs using methanol as solvent. Ambroxol hydrochloride has absorbance maxima at 248 nm, levocetirizine dihydrochloride has absorbance maxima at 230 nm and phenylephrine hydrochloride has absorbance maxima at 217 nm in methanol. The linearity was obtained in the concentration range of 5-35 μg/ml, 4-28 μg/ml and 2-28 μg/ml for ambroxol hydrochloride, levocetirizine dihydrochloride and phenylephrine hydrochloride, respectively. The concentrations of the drugs were determined by using simultaneous equations at three wavelengths. The mean recovery was 101.41 ± 0.82, 99.09 ± 0.95 and 99.52 ± 1.59 for ambroxol hydrochloride, levocetirizine dihydrochloride and phenylephrine hydrochloride, respectively. The method was successfully applied to combined dosage form because no interference from the excipients was found. The suitability of this method for the quantitative determination of ambroxol hydrochloride, levocetirizine dihydrochloride and phenylephrine hydrochloride was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of ambroxol hydrochloride, levocetirizine dihydrochloride and phenylephrine hydrochloride in combination. The results of analysis have been validated statistically and by recovery studies.
Spectrophotometric estimation of Betaxolol Hydrochloride in bulk powder and its dosage forms  [cached]
Suhagia B,Shah S,Rathod I,Patel H
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: A simple and sensitive spectrophotometric method has been developed for determination of betaxolol hydrochloride in bulk powder, and its pharmaceutical dosage forms. In the proposed method, betaxolol is oxidized with sodium periodate, to liberate formaldehyde, which is determined in situ, using acetyl acetone in the presence of ammonium acetate. A yellow coloured chromogen was obtained having absorption maxima at 405 nm. The method is found to be linear in the concentration range of 5-30 μg/ml, with a regression co-efficient of 0.9997. No significant difference was found between the proposed method and official method, when one tailed and two tailed t-test are applied. Various reaction parameters such as concentration of sodium hydroxide and sodium periodate, time required for oxidation, reagent concentration, and time for maximum colour intensity were optimized. The method was validated, and can be used successfully to assay betaxolol in bulk powder, and its pharmaceutical dosage forms viz. ophthalmic solutions.
Simultaneous spectrophotometric estimation of paracetamol and metoclopramide hydrochloride in solid dosage form  [cached]
Wadher S,Pathankar P,Puranik Manisha,Ganjiwale R
Indian Journal of Pharmaceutical Sciences , 2008,
Abstract: Two simple, accurate, rapid and economical spectrophotometric methods have been developed for the simultaneous determination of paracetamol and metoclopramide hydrochloride from tablet dosage form. The first method developed employs formation and solving simultaneous equations using 248.6 nm and 275.6 nm as two wavelengths for formation of equations. Second method is absorbance ratio in which wavelengths selected were 265.6 nm as isoabsorptive point and 275.6 nm as lmax of paracetamol. Both the drugs and their mixtures obey Beer-Lamberts law at selected wavelengths at given concentration range. The methods have been validated statistically and by recovery studies. The results of analysis have been validated statistically and by recovery studies.
Validated Spectrophotometric Methods For The Estimation of Lurasidone Hydrochloride in Bulk And Pharmaceutical Dosage Forms  [PDF]
Mali Nikita*,Patel Jignesh,Patel Mandev
International Journal of Research in Pharmacy and Science , 2012,
Abstract: Three new, simple and cost effective UV-Spectrophotometric methods were developed for the estimation of Lurasidone hydrochloride in bulk and pharmaceutical formulations. Lurasidone hydrochloride was estimated at 227 nm in UV-spectroscopic method (Method A), 237 nm in first order derivative spectroscopy (Method B) and scanned at 225.0 - 235.0 nm in Area under Curve method (Method C). Linearity range was found to be 5-30 μg/ml (Correlation coefficient r = 0.999in method A, r = 0.999 in method B and r = 0.999 in method C) in all the three methods. These methods were tested and validated for various parameters according to ICH guidelines. The proposed Methods were successfully applied for the determination of Lurasidone hydrochloride in pharmaceutical formulation (Tablets). The results of recovery were found to be 99.44-101.28 % for method A, -100.33- -101.46% for Method B, and for Method C % Recovery was found to be 99.83-100.76% which was within limits.(98-102%). Limit of Detection and Limit of Quantification were 0.2044, 0.6196 for method A, 0.6350, 1.9245 for method B and 0.0831, 0.2521 for method C. The results demonstrated that the procedure is accurate, precise and reproducible (% relative standard deviation <2%), while being simple, cheap and less time consuming and can be suitably applied for the estimation of Lurasidone hydrochloride in tablet dosage forms.
DEVELOPMENT AND VALIDATION OF DUAL WAVELENGTH UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND DESLORATADINE HYDROCHLORIDE IN THEIR COMBINED TABLET DOSAGE FORM  [PDF]
E.A. Sharma et al
International Journal of Pharmaceutical Sciences and Research , 2012,
Abstract: The present manuscript describes simple, sensitive, rapid, accurate, precise and economical dual wavelength spectrophotometric method for the simultaneous determination of Ambroxol Hydrochloride and Desloratadine Hydrochloride in combined tablet dosage form. 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 was based on determination of Ambroxol Hydrochloride at the absorbance difference between 253.2 nm and 258.5 nm and Desloratadine Hydrochloride at the absorbance difference between 301.2 nm and 314 nm. The linearity was obtained in the concentration range of 5 - 75μg/ml for both Ambroxol Hydrochloride and Desloratadine Hydrochloride. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The suitability of these methods for the quantitative determination of Ambroxol Hydrochloride and Desloratadine Hydrochloride was proved by validation and recovery study. The proposed methods were found to be simple and sensitive for the routine quality control application of Ambroxol Hydrochloride and Desloratadine Hydrochloride in pharmaceutical tablet dosage form.
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