The present manuscript describe simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of Rifampicin and Piperine in combined capsule dosage form. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Rifampicin and Piperine show an isoabsorptive point at 387 nm in methanol. The second wavelength used is 337 nm, which is the λ-max of Piperine in methanol. The linearity was obtained in the concentration range of 5-40 μg/ml for Rifampicin and 2-20 μg/ml for Piperine. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of Rifampicin. The method was successfully applied to pharmaceutical dosage form because no interference from the capsule excipients was found. The results of analysis have been validated statistically and by recovery studies.
The present manuscript describe simple, novel, rapid, precise, accurate, specific and cost effective Differential Spectrophotometric method for the determination of Ornidazole in Pharmaceutical formulation. Methanol was used as solvent. Differential Spectrophotometric method involves measurement of absorbance at 268 nm Peak minima and 313 nm Peak maxima. The amplitude, which is sum of magnitude of absorbances at above two wavelengths, was selected for the measurement. The drug comply with Beer Lambert's law over the linearity range 5-30 µg/ml. The method was validated as per ICH guideline rules in terms of Linearity, accuracy (recovery study), Precision (repeatability, intraday, interday validation), limit of detection, limit of quantification. All the validation parameters were found to be within acceptable limits. The method was found to be simple, novel, rapid, cost effective, accurate, and precise therefore is utilized for the routine analysis of drug in Pharmaceutical formulation.
This paper describes the development of a stability-indicating RP-HPLC method for duloxetine hydrochloride (DLX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. The drug was found to be stable to the dry heat condition attempted. Successful separation of the drug from the degradation products formed under stress conditions was achieved on a Phenomenex C18 column (250 4.6 mm id, 5 µm particle size) using acetonitrilemethanol0.032 M ammonium acetate buffer (55 + 05 + 40, v/v/v) as the mobile phase at a flow rate of 1.0 mL/min at 40°C temperature. Quantification was achieved with photodiode array detection at 290 nm over the concentration range 0.25 µg/mL with mean recovery of 101.048 ± 0.53 for DLX by the RP-HPLC method. Statistical analysis proved the method is repeatable, specific, and accurate for estimation of DLX. Because the method could effectively separate the drug from its degradation products, it can be used as a stability-indicating method.
The manuscript describes validated reversed-phase column high-performance liquid chromatographic (RP-HPLC) and first-derivative UV spectrophotometric methods for the estimation of levofloxacin (LFX) and ornidazole (ORNI) in combined dosage forms. The RP-HPLC separation was achieved on a Phenomenex C18 column (250 mm 4.6 mm id, 5 m) using KH2PO4 buffer (pH 6.8)methanolacetonitrile (70 + 15 + 15, v/v/v) mobile phase at a flow rate of 1.5 mL/min and ambient temperature (25 2<sup/>C). Quantification was achieved with photodiode array detection at 295 nm over the concentration range of 110 g/mL for both LFX and ORNI, with mean recovery of 101.7 0.23 and 99.23 1.57, respectively, by the RP-HPLC method. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first-order derivative spectra were obtained at N =1 (scaling factor), = 2.0 nm (wavelength interval), and the determinations were made at 310 nm (ZCP of ORNI) for LFX and 295 nm (ZCP of LFX) for ORNI over the concentration range of 240 g/mL for both LFX and ORNI. Mean recovery was 99.46 0.96 and 100.9 0.72, respectively, by the first-derivative UV spectrophotometric method. Standard and sample solutions were prepared with methanol as the solvent in both of the methods. These methods were found to be simple, accurate, precise, and sensitive and were applicable for the simultaneous determination of LFX and ORNI in combined dosage forms.
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