Recovery

A simple, selective, linear, precise and accurate HPLC method was developed and validated for rapid assay of Oxazepam in Bulk and Pharmaceutical tablet Formulation. Isocratic elution at a flow rate of 1.0 ml/min was employed.  The chromatographic analysis was performed on a ODS 5 μm (4.6 mm x 15 cm) or equivalent column at ambient temperature. The mobile phase consisted of Methanol: Water in the ratio of 65:35v/v. The UV detection wavelength was 230nm and 100µl sample was injected. Flow rate was found to be 1.0.  The retention time for Oxazepam was identified. The Average percentage recovery of the method was in the range of 0.5.  The method was validated as per the ICH guidelines. The method was successfully applied for routine quality control analysis of pharmaceutical formulation.

A simple, selective, linear, precise and accurate UPLC Method was developed and validated for rapid assay of Nordette in tablet Formulation. Isocratic elution at a flow rate of 0.4ml/min was employed on C8 1.7 µm (2.1 mm x 100 mm) Column at ambient temperature40 °C. Injection Volume was found to be 5.0 µl. The mobile phase consisted of Acetonitrile : Water  60:40 v/v which is filter through a 0.2 µm filter The UV detection wavelength was 220nm and 2µl sample was injected. The retention time for Ethinylestradiol, Levonorgestrel is found to be ± 1.4 minutes and ± 2.1 minutes respectively. A linear regression curve was constructed, and the correlation coefficients (R2) and assessment values calculated. The percentage RSD for both Ethinylestradiol, Levonorgestrel was found to be 1.5%.The Accuracy of method ranges between 97.0 – 102.8%.  The method was validated as per the ICH guidelines. The method was successfully applied for routine quality control analysis of pharmaceutical formulation.

The article, for the first time, reports High performance liquid chromatography [HPLC] method for estimation of Dapoxetine hydrochloride [DAP] and Tadalafil hydrochloride [TAD]. The analytical method was developed for both the drugs as API and for tablet dosage form. The separation of two drugs was achieved on High quality octa decyl silane [C18 250x 4mm i.d] 5μ column. The mobile phase consists of Acetonitrile and phosphate buffer in the ratio of 45:55. Mobile phase flow rate adjusted at 1 ml/min and pH at 4.2 using ortho phosphoric acid. The detection was carried out at a wavelength 254 nm. Retention time was found 4.46 and 10.11 min respectively for TAD and DAP. The method was validated for system suitability, linearity, accuracy, and precision and solution stability as per ICH guidelines. Linearity was obeyed in the range of 8-48 mg/ml and 24- 144 mg/ml with correlation coefficient of 0.997 and 0.998 for TAD and DAP respectively. Recovery studies were found within prescribed limits that was 98.83 for TAD and 98.93 for DAP respectively. Detection and quantification limit were found to be 0.225mg/ml and 0.682mg/ml for TAD and 0.163 mg/ml and 0.494mg/ml for DAP respectively which expresses higher sensitivity of the method. Assay results were found to be 98.52 % and 98.26 % in generic brand whereas 99.03 % and 98.11 in other brand for TAD and DAP respectively.

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of diclofenac sodium and eperisone hydrochloride in bulk and synthetic mixture. 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. Eperisone hydrochloride and diclofenac sodium show an isoabsorptive point at 270 nm in methanol. The second wavelength used is 255 nm, which is the λ-max of eperisone hydrochloride in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both eperisone hydrochloride and diclofenac sodium. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of eperisone hydrochloride. The method was successfully applied to pharmaceutical dosage form because no interference from the synthetic mixture excipients was found. The suitability of this method for the quantitative determination of eperisone hydrochloride and diclofenac sodium was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of eperisone hydrochloride and diclofenac sodium in synthetic mixture or pharmaceutical dosage form. The results of analysis have been validated statistically and by recovery studies. 

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of Eperisone hydrochloride and Aceclofenac sodium in mixture. The method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent. Eperisone hydrochloride has absorbance maxima at 255 nm and Aceclofenac sodium has absorbance maxima at 275 nm in methanol. The linearity was obtained in the concentration range of 4-20 μg/ml and 4-20 μg/ml for Eperisone hydrochloride and Aceclofenac sodium, respectively. The concentrations of both drugs in synthetic mixture were determined by using simultaneous equations. The mean recovery was 100.34 ± 0.27 and 100.64 ± 0.71 for Eperisone hydrochloride and Aceclofenac sodium, respectively. The method was applied for the determination of these drugs in mixture. The suitability of this method for the quantitative determination of Eperisone hydrochloride and Aceclofenac sodium was proved by evaluating different validation parameters. The proposed method was found to be simple and sensitive for the routine estimation of these drugs in combination. The results of analysis have been validated statistically and by recovery studies.  

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of ibuprofen and chlorzoxazone in bulk and synthetic mixture. 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. Ibuprofen and Chlorzoxazone show an isoabsorptive point at 227 nm in methanol. The second wavelength used is 221 nm, which is the λ-max of Ibuprofen in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both Ibuprofen and Chlorzoxazone. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of Ibuprofen. The method was successfully applied for the determination of these two drugs in synthetic mixture. No interference was observed from excipients present in the synthetic mixture. The suitability of this method for the quantitative determination of Ibuprofen and Chlorzoxazone was proved by validation. The proposed method was found to be simple and sensitive for the routine analysis of these two drugs in synthetic mixture. The results of analysis have been validated statistically and by recovery studies. 

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of Gatifloxacin sesquihydrate and Prednisolone Acetate in  mixture. The method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent.Gatifloxacin sesquihydrate has absorbance maxima at 293 nm and Prednisolone Acetate has absorbance maxima at 243 nm in methanol. The linearity was obtained in the concentration range of 2-12 μg/ml and 2-24 μg/ml for Gatifloxacin sesquihydrate and Prednisolone Acetate, respectively. The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The mean recovery was 99.19 ± 0.22 and 99.64 ± 0.37 for Gatifloxacin sesquihydrate and Prednisolone Acetate, respectively. The method was successfully applied to laboratory prepared synthetic mixture because no interference from the mixture excipients was found. The suitability of this method for the quantitative determination of Gatifloxacin sesquihydrate and Prednisolone Acetate was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of  Gatifloxacin sesquihydrate and Prednisolone Acetate in combination. The results of analysis have been validated statistically and by recovery studies. 

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of diclofenac sodium and tolperisone hydrochloride in bulk and synthetic mixture. 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. Tolperisone hydrochloride and diclofenac sodium show an isoabsorptive point at 267 nm in methanol. The second wavelength used is 255 nm, which is the λ-max of tolperisone hydrochloride in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both tolperisone hydrochloride and diclofenac sodium. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of tolperisone hydrochloride. The method was successfully applied to pharmaceutical dosage form because no interference from the synthetic mixture excipients was found. The suitability of this method for the quantitative determination of tolperisone hydrochloride and diclofenac sodium was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of tolperisone hydrochloride and diclofenac sodium in synthetic mixture or pharmaceutical dosage form. The results of analysis have been validated statistically and by recovery studies.

The present manuscript describe simple, sensitive, rapid, accurate, precise and cost effective dual wavelength spectrophotometric method for the simultaneous determination of Rifampicin and Piperine in combined capsule dosage form. The utility of dual wavelength data processing program is its ability to calculate unknown concentration of components of interest in a mixture containing an interfering component. 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 Rifampicin at the absorbance difference between 286 nm and 357 nm and Piperine at the absorbance difference between 356 nm and 479 nm. The linearity was obtained in the concentration range of 10-60 μg/ml for Rifampicin and 1-10 μg/ml for Piperine. The mean recovery was 98.40 ± 0.48 and 98.59 ± 0.46 for Rifampicin and Piperine, respectively. The method was successfully applied to pharmaceutical dosage form because no interference from the capsule excipients was found. The suitability of these methods for the quantitative determination of Rifampicin and Piperine was proved by validation. The proposed methods were found to be simple and sensitive for the routine quality control application of Rifampicin and Piperine in pharmaceutical capsule dosage form. The results of analysis have been validated statistically and by recovery studies.