The main objective of the study is to establish simple, precise and rapid RP-HPLC method for determination of diazepam and its decomposition products present in bulk and pharmaceutical dosage form. Various parameters that can potentially affect the analytical method were investigated and optimized. The compounds were well resolved in an isocratic method using the mobile phase composition of potassium dihydrogen phosphate buffer(0.05M) along with diluted o-phosphoric acid adjusted to pH 4.5: methanol (40:60v/v) at a flow rate of 1 ml/min using C18 (25cm x 0.46 cm) Hypersil BDS column. The detection was carried out at wavelength of 248nm.The retention time of diazepam was 3.3 min. The developed method was validated by evaluating various parameters such as linearity, precision, accuracy, robustness, specificity, limit of detection, and limit of quantification according to the international council for harmonization guidelines. The standard calibration curve was obtained in the concentration range of 20µg/ml for diazepam. The % of label claim was found out to be 93.66 for diazepam. Observation of all these parameters leads to the point that developed RP-HPLC method is accurate, precise, linear, specific and robust. It can be successfully adopted for routine quality control analysis of Diazepam in bulk and pharmaceutical dosage form without any interference.

Objective: The objective of this research was to develop and validate a simple ultraviolet (UV) spectrophotometric method for simultaneous determination of sildenafil citrate and dapoxetine hydrochloride in a pharmaceutical formulation.Methods: Two simple UV spectrophotometric methods have been developed for simultaneous determination of sildenafil citrate and dapoxetine hydrochloride. For both methods, stock solutions were prepared in methanol followed by the further required dilutions with methanol. Proposed dual-wavelength method and ratio derivative method, the wavelength of maximum absorption for sildenafil citrate and dapoxetine hydrochloride was 292 nm and 231 nm, respectively.Results: In both methods, the linearity range lies between 10 and 60 μg/ml for sildenafil citrate and 2–12 μg/mL for dapoxetine hydrochloride with their respective wavelengths. By dual-wavelength method, the percentage of sildenafil citrate and dapoxetine hydrochloride was found to be 101.3% and 100.3%, respectively.Conclusion: Result obtained in this research work clearly indicated that both these methods were found to be accurate, precise, stable, and robust as indicated by low values of percentage relative standard deviation. Thus, the present study gives an excellent method for the determination of both the drugs in combined tablet formulation.

Objective: The objective of this research was to develop and validate a simple ultraviolet (UV) spectrophotometric method for simultaneous determination of sildenafil citrate and dapoxetine hydrochloride in a pharmaceutical formulation.Methods: Two simple UV spectrophotometric methods have been developed for simultaneous determination of sildenafil citrate and dapoxetine hydrochloride. For both methods, stock solutions were prepared in methanol followed by the further required dilutions with methanol. Proposed dual-wavelength method and ratio derivative method, the wavelength of maximum absorption for sildenafil citrate and dapoxetine hydrochloride was 292 nm and 231 nm, respectively.Results: In both methods, the linearity range lies between 10 and 60 μg/ml for sildenafil citrate and 2–12 μg/mL for dapoxetine hydrochloride with their respective wavelengths. By dual-wavelength method, the percentage of sildenafil citrate and dapoxetine hydrochloride was found to be 101.3% and 100.3%, respectively.Conclusion: Result obtained in this research work clearly indicated that both these methods were found to be accurate, precise, stable, and robust as indicated by low values of percentage relative standard deviation. Thus, the present study gives an excellent method for the determination of both the drugs in combined tablet formulation.

Tetramethylthionine chloride is approved by the FDA for the treatment of paediatric and adult patients with acquired methaemoglobinaemia. The objective of this research was to develop and validate an Ultraviolet (UV) spectrophotometric method for quantification of Tetramethylthionine chloride in cleaning control swab sample from manufacturing equipment surfaces. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation and quantification of Tetramethylthionine chloride which is going to be used for the evaluation of cleaning in cleaning validation. The optimum conditions for the quantitative analysis of the drugs were established. The maximum wavelength (λmax) was found to be 663nm. The percent recovery of Tetramethylthionine chloride for 50.0%, 100.0% and 150.0% were 99.13, 97.76 and 101.18 respectively. Linearity of Tetramethylthionine chloride for Validation showed a good linear relationship with Correlation Coefficient (r2) value of 0.999 was obtained. Validation was performed according to the ICH guidelines of Analytical Method Validation. The Sample Solution was chemically stable up to 36 hours. The proposed may be suitable for the Estimation and Quantification of Tetramethylthionine chloride for evaluation of cleaning in cleaning validation for quality control purposes.

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