A simple reverse phase HPLC method was developed and validated for the determination of Bromazepam and his decomposition products present in pharmaceutical dosage form. A Lichrospher 100 RP 8 column (250 × 4.0 mm, 5μm) is used as stationary phase. An isocratic mode with mobile phase consisting of methanol and Potassium dihydrogen phosphate buffer (KH₂PO₄) (pH 7.0; 0.02M) in ratio of 55:45 (v/v) at a flow rate of 0.9 ml/min and effluent was monitored at 238 nm. Chromatogram showed a peak of Bromazepam (BZP) at retention time of 8.36 ± 0.1 min. The linearity range was found to be 84–156 μg/ml of Bromazepam with correlation coefficient of 0.9997. The method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection and robustness. Recovery of BZP was found to be in the range of 98.6–101.2%. The limit of detection and limit of quantitation for estimation of BZP was found to be 0.15μg/ml and 0.51μg/ml, respectively. This showed that proposed method is rapid, simple, precise, linear, robust, and accurate which is useful and economic for routine analysis of BZP in pharmaceutical dosage forms.

Human Interferon Alpha 2b (rhIFN α-2b) stimulates the immune system to fight the viral infection by inhibiting the ability of the viruses to divide and reproduce. It is indicated for treating chronic hepatitis B and C, Hairy Cell Leukemia and Malignant Melanoma as an adjuvant to surgical treatment. The recombinant version of IFN α-2b is the only interferon approved for the treatment of both chronic hepatitis B and C. It can completely eliminate chronic hepatitis B infections and in case of people with chronic hepatitis C it is used in combination with Ribavirin. The present study was performed to assess the pre-clinical safety of recombinant IFN α-2bon male and female Wistar Rats. All animals were conditioned, randomized and were dived in to 4 groups (each group containins 6 males and 6 females) and were administered with formulated IFN α-2bat different dose levels viz. Therapeutic Dose (TD), Average Dose (5X of TD), High Dose (10X of TD) and formulation buffer (VC) for a period of “28 Days” repeatedly.All animals were observed for a period of 28 days for clinical signs of toxicity, in-life phase of animals, cage side observations and body weight and food consumption. The blood samples were collected for hematology and clinical chemistry analysis at 48 hrs after the administration of last dose. Similarly, animals were necropsied and vital organs collected and subjected to histopathological examination.

This present bioequivalence study was designed to determine the bioavailabilityand bioequivalence of Olmesartan 40mg+Amlodipine 10mg+ Hydrochlorothiazide 25mg  tablets in comparison with TRIBENZOR^® tabletsafter single dose administration under fasting conditions in healthy adult male subjects. Therefore the design of an open label, balanced, randomized, single dose, two-treatment, two-period crossover study with a wash-out period of at least 15 days was used. The pharmacokinetic parameters including C_max, AUC_0-t, AUC_0-inf and T_max were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (C_max, AUC_0-t and AUC_0-inf) 90%CI were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The 90% confidence intervals for the ratios of the ln-transformed Cmax and AUC_0®72 for Olmesartan were 98.788%-99.602% and 98.637%-98.835% respectively and for Amlodipine were 99.976%-101.918% and 104.957%-111.670% respectively and for  hydrochlorothiazide were 98.082%-99.623% and 95.301%-98.406% respectively. Eighteen volunteers had completed all treatment periods. The pharmacokinetic parameters of test product assessed were within the acceptable limits of Bioequivalence 80-125%.

This present bioequivalence study was designed to determine the pharmacokinetic, bioavailability and bioequivalence of Fenofibrate 250 mg Sustained Release Capsules in comparison with Secalip^®SR 250 mg capsules (containing Fenofibrate 250 mg). The primary pharmacokinetic parameters (C_max, AUC_0-t and AUC_0-inf) 90%CI were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The geometric mean ratios (Test/Reference) between the two products of extended-release Fenofibrate SR capsule under fed condition were 104.91% (92.86%-118.53%) and 114.41% (103.43%-124.55%) for C_max ratios, 102.24% (95.95%-108.94%) and 105.27% (96.76%-114.53%) for AUC_0-t ratios and 101.66% (95.73%-107.97%) and 104.71% (96.13%-114.05%) for AUC_0-inf ratios of Fenofibrate. Fourteen volunteers had completed both treatment periods. There was no significant difference of the T_max parameter between the two formulations (p >0.05). No serious adverse events related to the study drugs were found.

This present bioequivalence study was designed to determine the bioavailabilityand bioequivalence of Agomelatine 25 mg tablets in comparison with VALDOXAN^® tabletsafter single dose administration under fasting conditions in healthy adult male subjects. Therefore the design of an open label, balanced, randomized, single dose, two-treatment, two-period crossover study with a wash-out period of at least 7 days was used. The pharmacokinetic parameters including C_max, AUC_0-t, AUC_0-inf and T_max were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (C_max, AUC_0-t and AUC_0-inf) 90%CI were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The 90% confidence intervals for the ratios of the ln-transformed Cmax and AUC_0®17 for AGOMELATINE were 96.01% and100.94 %respectively. Seventeen volunteers had completed all treatment periods. There was no significant difference between the two formulations. No serious adverse events related to the study drug were found.