Anjan De

A new, simple, rapid and novel spectrophotometric method has been developed for estimation of Ramipril (RAM) and Hydrochlorothiazide (HCT) in bulk and combined pharmaceutical formulations using First order derivative method. It is a useful means of resolving the spectra and eliminating the interference. It involves conversion of normal spectrum to first and second or higher order spectra where the amplitude in the derivative spectra is proportional to the Conc. of analyte provided the Beer’s law is obeyed.The successive development of zero crossing technique was accordingly due to the feature of derivative spectra to show singles with both positive and negative value. This technique exploits the single crossing through the abscissa axis, for given components. Zero crossing technique is particularly effective in the analysis of several complex mixtures, when  peaks overlapping are present in the corresponding zero order spectra. λmax of RAM was found at 341nm and HCT at 229nm in ethanol respectively. Beer’s law obeyed in concentration range of 0.1‐ 0.5 μg/ mL for RAM and 0.25‐ 1.25 μg/ mL for HCT respectively by the method. This method was validated for precision, reproducibility, linearity and accuracy as per ICH guidelines. The proposed method is recommended for routine analysis since this is rapid, simple, accurate, cost effective , also sensitive and specific. It involves neither heating nor use of any hazardous organic solvent for separation of the combination.

The nasal route has gained importance in recent decades as a non-invasive drug application route that offers many advantages for the introduction of drugs into systemic circulation. Its major advantage is the rapid absorption of drugs and therefore quick onset of their effect. In addition, it has the advantage of avoiding the hepatic first-pass effect. Thus, nasal drug delivery may be used for either local or systemic effects. Cancer induced nausea and vomiting is one of the major side effects of the cancer chemotherapy. For the treatment of the CINV the use 5HT3 recepter antagonist is the most effective. Ondansetron has a oral bioavailability of 60% due to the first pass metabolism. So our objective was to prepare an in situ nasal gel of the Ondansetron using PF-127 as the thermo reversible polymer. There are many approaches for increasing the residence time of drug formulations in the nasal cavity resulting in enhanced drug absorption. We used HPMC E15 and Chitosan as the mucoadhesive polymer to increase the nasal residence time of the formulation. To increase the permeation we used Polyethylene Glycol 400 and Propylene glycol as the permeation enhancer. Further,  a 3-factor, 2-level full factorial design (23) study was carried out to optimize the Ondansetron gel with PF 127 amount (%, X1), permeation enhancers (PEG 400 1%/PPG 1%, X2) and polymers (HPMC E15 1 %/Chitosan 0.5 %, X3) as the prime selected independent variables, which were varied at 2 different levels (low and high). The effect of formulation variables on the response variables were statistically evaluated by using a commercially available software package Design-Expert® version 8.0 (Stat-Ease, Inc.).The formulation Om2 was found to be the best composition formula based on statistical finding, while conformation experiment also proves this result.