Current Issue : October - December Volume : 2013 Issue Number : 4 Articles : 6 Articles
A fixed dose combination of Cefixime Trihydrate (CEF) and Azithromycin Dihydrate (AZI) is used in ratio of 2:2.5 as tablet for the treatment of the respiratory tract infections, typhoid and pneummonia. A simple, precise and accurate HPTLC method was developed and validated for determination of CEF & AZI in tablet. The compounds were separated on aluminium-backed silica gel 60 F254 plates with Toluene: Chloroform: Methanol: Ammonia (4: 2: 12: 0.2 v/v/v/v) as mobile phase. These systems were found to give sharp spots of CEF and AZI with the Rf value of 0.76 �±0.02 and 0.26 �±0.02 respectively. Densitometric analysis of CEF and AZI were done at 289 nm and 483 nm, respectively. AZI spot is visualized by using Sulfuric Acid : Ethanol (1: 4 v/v) & heated at 120 �°C for 5 min. Method was found linear in the range of 250-1500 ng/band for CEF and 312.5-1875 ng/band for AZI with the correlation coefficient (r2) 0.998 for both drugs. The method was validated for linearity, precision, accuracy, limit of detection (LOD) and limit of quantitation (LOQ). Analysis proved that method is Reproducible, precise, selective, and accurate for simultaneous estimation of CEF and AZI....
A simple, reproducible, sensitive and cost effective stability indicating micellar liquid chromatographic (MLC) method has been developed for determination of Tacrolimus (TCR) in bulk and capsule dosage form. The analysis was carried out on Thermo Scientific Hypersil BDS cyano RP column (250 mm x 4.6 mm, 5 µm), using acetonitrile: methanol: water: 0.1 N H2SO4 (15:10:70:5 v/v/v/v) containing sodium lauryl sulphate (0.01 M) as a mobile phase at a flow rate of 1.5 ml/min and UV detection at 215 nm. Beer's law was found to obey in the concentration range of 50-150 µg/ml with correlation coefficient of 0.9981. The retention time for TCR was found to be 2.61 min. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.1383 µg/ml and 0.4192 µg/ml respectively. The % relative standard deviations for intra-day and inter-day precision studies were found to be 0.08-0.18 and 0.31-0.57, respectively. The % recovery of TCR was found to be in the range 98.42 to 100.34. The proposed method was applied successfully for the determination of TCR in bulk and its capsule dosage form....
Artesunate and Mefloquine is Antimalarial drug belonging to class Sesquiterpine lactones and Quinoline-methanol for the treatment of uncomplicated malaria. Only RP-HPLC, UV spectrophotometric and HPTLC method was reported for the estimation of Artesunate and Mefloquine hydrochloride either alone or in any other drug combination .There was no reported stability indicating HPLC method for the estimation of Artesunate and Mefloquine Hydrochloride. So, purpose of the present work is to a develop and validate simple, precise and stability indicating RP-HPLC method for simultaneous estimation of Artesunate and Mefloquine Hydrochloride in tablet dosage form according to ICH guidelines and to communicate here rapid and cost-effective quality-control tool for routine qualitative analysis of two drugs their combined dosage forms by Chromatographic Methods. RP-HPLC method for the estimation of Artesunate and Mefloquine Hydrochloride was developed by using C18 (250mm X 4.6mm, 5µm) as a stationary phase and Acetronitrile: Phosphate Buffer adjusted with triethylamine (70:30 v/v), pH 3.5 as a mobile phase at 225 nm. RP-HPLC method retention time for Artesunate and Mefloquine Hydrochloride was found to be 3.13 and 4.15 with a linearity range of 50-150µg/ml (R2 =0.997) and 110-330µg/ml (R2 =0.997). Recovery found was found to be 98-101% for Artesunate and 99.3- 101.3% for Mefloquine Hydrochloride. The Stability indicating method by RP-HPLC were found to be accurate, precise, specific, simple and stability indicating. Artesunate and Mefloquine hydrochloride show degradation in acidic, alkaline, oxidative and thermal condition....
This paper describes the three multipurpose methods for simultaneous estimation of Ambroxol Hydrochloride (AMB) , Guaiphensin (GUA), Cetirizine Hydrochloride (CET) and Phenylephirine (PHE) whether they were present in binary combination of any two drugs, tertiary combination of any three drugs or quaternary combination of all four drugs. Such methods were developed through applying chemometrics and also called multivariate analysis. The calibration model of 36 composite mixtures were prepared and three methods named Classical Least Square (CLS), Inverse Least Square (ILS), Principle Component Regression (PCR) has been developed and cross validated with mean recoveries of 101.4%, 100.8 % ,99.6%,99.9% for AMB , GUA, CET and PHE. A different validation set was also formed to estimate figure of merits which are Limit Of Quantification (LOQ), found to be 2.9 �µg/mL, 3.2 �µg/mL, 1.4 �µg/mL and 6.3 �µg/mL for AMB, GUA, CET and PHE, Limit of Detection (LOD) was 1.01 �µg/mL, 1.07 �µg/mL, 0.48 �µg/mL and 2.11 �µg/mL for AMB, GUA CET, and PHE. The model was then applied to 6 different market combinations in binary, tertiary or quaternary forms, the statistics were applied to conclude that there is no significant difference between the methods. The accepted t-value (less than 5.42) of marketed samples confirms that these all methods are suitable for routine assay of selected drugs in binary/ tertiary or quaternary combination....
Simple, rapid, precise, accurate and novel orthogonal function spectrophotometry (OFS) in combination with zero order UV-spectrophotometry was developed and validated for simultaneous estimation of Lornoxicam (LOR) and Tolperisone Hydrochloride (TPH) in tablet dosage form. This method involves estimation of TPH by six point quadratic orthogonal polynomials function with equally spaced intervals at 240, 245, 250, 255, 260 and 265 nm which eliminate interference of LOR and estimation of LOR at 385 nm in zero order spectra where TPH shows no characteristic absorption. Developed method was validated according to ICH guidelines. The calibration graph was found to be linear in the range of 4.0-14.0 μg/ml for both LOR and TPH with coefficient of determination (r2) value greater than 0.999. Accuracy of method was confirmed by recovery studies showing recovery between 98% to 102%. Reproducibility and repeatability was confirmed by intraday and interday precision where % RSD was found to be less than 2. The method was successfully applied for estimation of LOR and TPH in tablet dosage form....
A sensitive, reproducible and rapid reverse phase high performance liquid chromatographic methods were developed and validated for the determination of Ziprasidone Hydrochloride Monohydrate (ZHM) in presence of its degradation products in pure form and pharmaceutical formulations. ACE-5 C18 column (150Ã?â??4.6mm, 5Ã?µ) was used with a mobile phase containing a mixture of Acetonitrile : Phosphate Buffer pH 3.2 in the ratio of (40:60). The flow rate was 1ml/min and effluents were monitored at 219 nm and eluted at 2.83 min. Calibration curve was plotted with a range from 10-50 Ã?µg/ml .The method was validated for the parameters like accuracy, precision, robustness and system suitability parameters. The precision, ruggedness and robustness values were also within the prescribed limits (< 1% for system precision and < 2% for other parameters). The LOD and LOQ was found to be 0.1282 Ã?µg/ml & 0.3885 Ã?µg/ml respectively....
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