RP-HPLC method is use for the determination of drugs in single or in combination with other component. RP-HPLC technique is widely use for the separation and analysis of drugs that is present in combined formulation. This technique is also used for the separation of drugs from the excipients that are present in the formulation. Analytical method is developed to carry out the determination of drugs or component present in the formulation. Validation studies are performed in order to assess the validation parameters for analytical method development in accordance to ICH guideline. In this article we can understand steps of method development and validation for the new drug or component by using RP-HPLC technique.
B. Prathap*, G. H. Srinivasa Rao, S. Jegannath, K. V. Swathikrishna, V. Priyanka.
A simple and economical ratio spectra derivative spectrophotometric method for Ibuprofen (IBU), Paracetamol (PAR), and Chlorzoxazone (CLR) combination on laboratory prepared tablet formulation has been developed. The method is also precise and accurate. The principle of method is to obtain first derivative of ratio spectra and measuring amplitude at selected wavelength. The first derivative amplitudes of ratio spectra measured at 215.18 nm, 241.70 nm and 274.43 nm for measuring the response of IBU, PAR, CLR, respectively. Beer’s law is obeyed in the concentration range of 4-20 μg ml-1 for IBU, 3.2-16 μg ml-1 for PARA and 2.5-12.5 μg ml-1 for CLR. The % assay was found to be in the range 98.85 - 101.0 % for IBU and 98.91 - 101.72 % for PAR and 98.71-101.2 % for CLR by the proposed method. The method was validated with respect to linearity, precision and accuracy. Drug recovery for IBU, PAR and CLR was found in the range of 98.72 - 101.2 %, 98.65 - 100.64 % and 98.32-101.32 %, respectively. % RSD was found in the range of 0.65-0.93, 0.87-1.02, 0.57-1.06 for IBU, PAR, CLR, respectively.
GRDDS is an approach to prolong gastric residence time and are suitable for drug having low bioavailability and therapeutic efficacy. Atenolol is a β-blocker used for the maintenance of hypertension. The biological half-life of Atenolol is 6-7 hours with poor bioavailability up to 50%. In the present study, direct compression method was employed to prepare atenolol floating tablets using different polymers and gas generating agent. Floating tablets were characterized for pre and post-compression parameters like, drug excipients interaction studies, swelling index, hardness, friability, weight variation, drug uniformity and In vitro drug release study. FTIR studies reveals that there was no interaction between the excipients and drug used in the formulations. Pre and Post-compression parameters of floating tablets of atenolol were in the standard limits. From the studies it was concluded that, among various formulation, F6 showed better and prolong release over a period of 24 hours. Hence this formulation shows, that FDDS will be a promising one to improve the bioavailability and therapeutic efficacy of atenolol.
Saroj Kr. Sah*, G. Santosh Kumar, V. Rajashekhar, K. A. Sridhar, R. Manasa Deepa.
Oral sustained drug delivery system is one of the most effective form to hold the drugs in biological system for a desired duration and thereby improve their biological half-life of the drug. Diclofenac sodium belongs to class of NSAIDs used extensively in the treatment of various diseases (Rheumatoid arthritis, ankylosing spondylitis, dental pain etc). The present study is focused to formulate Diclofenac sodium matrix tablets by direct-compression using natural polymers (Xanthan gum, Guargum). Formulated tablets were taken to pre-compression and post compression parameters analysis. Reports of pre-compression study shows granules prepared were free following with good compressibility. Post-compression parameters such as hardness, friability, weight variation, thickness and drug content were found in the range of 3-5 kg/cm2, less than 1%, 295 to 305 mg, 2 to 3 mm and 97 to 99% respectively. Among various formulations (F1-F12), F12 showed 98% of drug release during 12hrs of release study.
C. Aashutosh*, G. Ghanshyam, R. Manasa Deepa, N. Kavya, V. Rajashekhar, K. A. Sridhar.
Tizanidine is a short acting muscle relaxant drug. Tizanidine hydrochloride is a central adrenergic agonist acts by inhibiting the excitatory amino acids release in spinal interneurons. Fast dissolving tablets are disintegrating or dissolving rapidly in the saliva without the need of water and are designed to dissolve in saliva remarkably fast, within a few seconds. The current study aimed to formulate fast dissolving tablets of Tizanidine hydrochloride using, super disintegrants such as Kyron T-314, Crospovidone and Emcosoy. Formulated tablets were involved to evaluate hardness test, weight variation test, thickness test, friability test, drug content, wetting time, water absorption ratio, In vitro release studies. The results were found satisfactory as per the specified in monographs. The study report reveals that formulation CP3 (Crospovidone based formulation) and formulation KY3 (Kyron T-314 based formulation) showed highest release rate, 98.10% and 96.17% respectively within 5 min. Moreover, it suggests, fast dissolving tablets will be a promising delivery system to improve therapeutics efficacy of Tizanidine.
V. Rajashekhar*, C. Puja, K. Rajesh, A. N. Pavan Kr, R. Manasa Deepa, K.A. Sridhar.