Mrinal

Fluindione is an oral anticoagulant drug. A simple and rapid and was validated stability indicating HPLC method for Fluindione was successfully developed and was validated. This method is based on HPLC separation followed by UV detection at 285 nm. HPLC method was developed on a Symmetry thermo C18 (4.6 x 250 mm) column with a mobile phase consisting of 10mM di-sodium hydrogen phosphate buffer pH 3.5: methanol 15:85 v/v, pumped at 1.0 ml min-1 flow rate. The pH of buffer was adjusted to 3.5 with ortho phosphoric acid. The column was maintained at ambient temperature and 20μl of solutions were injected. The eluted compound was detected by using PDA detector. Fluindione was eluted at 2.4 ± 0.2 min. Stress degradation study shows that sample degraded with acid and base hydrolysis, under oxidation, thermal and photolytic stress conditions. The method was validated in accordance with requirement of ICH guidelines.

Eletriptan hydrobromide is used for the acute treatment of attacks of migraine with or without aura in adults. It is also used in Vascular Headaches. To develop stability indicating method, the technique of forced degradation studies was adopted. Eletriptan hydrobromide solution was spotted on plates precoated silica gel 60F254. The mobile phase used was Methanol: Toluene (9.5: 0.5 v/v) and quantification was carried out at wavelength225 nm. The system showed a peak for Eletriptan hydrobromide at Rf value of 0.23 ± 0.03.The Drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. Stress testing of Eletriptan hydrobromide was carried out according to the International Conference of Harmonization (ICH) guideline Q1A (R2).The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 500–2500 ng/band concentrations with correlation coefficient value of 0.9979. The accuracy of the method was established based on the recovery studies. The LOD and LOQ of Eletriptan hydrobromide was found to be 31.03 ng/band and 94.06 ng/band respectively. Among various stress conditions, Eletriptan hydrobromide showed considerable degradation under alkali and acid catalyzed hydrolysis, oxidative and photolytic condition.

This study explored the effect of bark of Holarrhena antidysenterica Linn in management of diabetic neuropathy in experimental animals. Adult Wistar rats (either sex; 250-275 g) were injected with streptozotocin (50 mg/kg; i.p.) to induce diabetes. Methanol extract of bark of Holarrhena antidysenterica was administered in 3 doses (200, 400 and 600 mg/kg; p.o.) to rats for 28 successive days daily after 4 weeks of STZ administration. After 8 weeks, the neuropathic activity was evaluated using Open field test, Tail Flick test, Cold Allodynia and Formalin test. Afterwards, sciatic nerve was used for TBARS, GSH, Nitrite, Catalase and protein estimations. STZ induced diabetic neuropathy caused decrease in tail-flick latency time in radiant heat test and decreased allodynic response in tail-immersion (cold water) test. STZ caused increase in blood glucose, Glycosylated Haemoglobin and blood Cholesterol levels. Furthermore, activity of endogenous antioxidants like GSH and catalase significantly decreased; however, TBARS and nitrite levels were increased. Administration of MEHA for 28 days prevented the development of diabetic neuropathy as evident from reversed (p< 0.05) cold allodynia and tail flick latency (p< 0.05) as compared to diabetic control group. Glycosylated haemoglobin and cholesterol levels were significantly decreased (p< 0.05) in rats as compared to diabetic control group. MEHA treated rats showed significant decreased TBARS and nitrite levels and increased GSH and Catalase level. Thus, Holarrhena antidysenterica not only improved the diabetic condition but also reversed neuropathic pain through modulation of oxidative–nitrosative stress.

A simple and sensitive stability indicating HPTLC method has been developed and validated for estimation of Palonosetron hydrochloride. Separation of the drug was carried on aluminium plates precoated with silica gel 60 F254 using Ethyl acetate: Methanol: Triethylamine (6:3:1 v/v/v) as mobile phase. The retention factor (Rf) for Palonosetron hydrochloride was found to be 0.50 ± 0.04. The detection was carried at 242 nm. Stress testing of Palonosetron hydrochloride was carried out according to the International conference on harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. Palonosetron hydrochloride showed considerable degradation under oxidative condition. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 250–1500ng/band concentrations with correlation coefficient 0.994. The accuracy of the method was established based on the recovery studies. The LOD and LOQ were 11.81ng/band and 35.78ng/band respectively.

A modified liquid- liquid extraction based reverse phase high performance liquid chromatographic method has been developed and validated for the determination of Furosemide in human plasma. The chromatographic separation was achieved with Pinnacle C18 column (250 x 4.60 mm, 5μm i.d.) and a mobile phase comprising of a mixture of Methanol: Water: Triethylamine (70:30:0.1v/v/v), pH adjusted to 3.2 with orthophosphoric acid was used with UV detection at 274nm. The internal standard spironolactone structurally related to Furosemide was used. The retention time for Furosemide and spironolactone was found to be 3.75min and 8.12min respectively.  A calibration curve was linear in the concentration range of 200-2200ng/ml for Furosemide in blank human plasma. The % recovery from human plasma was found to be in the range of 89.41 to 93.91 for Furosemide. The lower limit of quantitaion was found to be 200ng/ml and no interference was found from endogenous compound. The specificity, linearity, accuracy, precision and stability of the method were evaluated from spiked human plasma sample as per EMA (European Medicine Agency) guideline. The method can be used for supporting therapeutic drug monitoring and pharmacokinetic studies.