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T. Venkatachalam ¹, K. G. Lalitha ²

Affiliations
1 Department of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, B. Komarapalayam - 638 183, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, ULTRA College of Pharmacy, Madurai - 625 020, Tamil Nadu, IN

Abstract

A simple, accurate and precise densitometry method for the simultaneous estimation melatonin (MEL) and zolpidem (ZOL) in pharmaceutical dosage forms has been developed and validated. Separation of drugs was carried out using toluene: n-butanol:glacial acetic acid:water (1:4:2:2v/v/v/v) as mobile phase on precoated Silica Gel 60F₂₅₄ plates. The densitometry evaluation of spot was carried out at 254 nm. The R_f value for MEL and ZOL were found to be 0.87±0.01 and 0.59±0.01 respectively. The method was validated with respect to linearity, accuracy, precision and robustness as per the International Conference on Harmonization (ICH) guidelines. The drug response with respect to peak area was linear over the concentration range 150-900 ng/spot and 250-1500 ng/spot for MEL and ZOL respectively, limit of detection and limit of quantitation were found to be 14.96 ng/spot and 45.60 ng/spot for MEL and 19.53 ng/spot and 59.24 ng/spot for ZOL. The percentage recovery of MEL and ZOL were found be 99.04-99.35% and 98.11-98.77% respectively. The % RSD values for (intra-day RSD 0.26-0.56% and inter-day RSD 0.36-0.78 %for MEL and intraday RSD 0.18-0.31% and inter day 0.23-0.31% for ZOL). It was observed that the proposed HPTLC method could be used for efcient analysis and monitoring of the MEL and ZOL in combined tablet dosage forms.

Keywords

Melatonin, Zolpidem, HPTLC, Validation.

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P. Kalaiselvi ¹, K. G. Lalitha ²

Affiliations
1 Department of Pharmaceutical Analysis, JKKMMRF College of Pharmacy, B. Komarapalayam - 638 183, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai - 625 020. TamilNadu, IN

Abstract

A reliable simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for estimation of lafutidine (LF) and domperidone (DP) in combined tablet dosage forms. The analysis was performed on 10×20 cm aluminium-precoated plates coated with 0.2 mm layers of silica gel 60 F₂₅₄ (E-Merck, Germany) with ethyl acetate:methanol:toluene:acetone:glacial acetic acid (1.0:1.5:4.0:2.0:0.2 v/v/v/v/v) as mobile phase. Camag TLC Scanner III was used for the UV densitometric scanning at 285 nm. This system was found to give a compact spot of LF and DP at retention factor (R_f) value of 0.32±0.03 and 0.65±0.02 respectively. Linear regression analysis data for the calibration curve showed good relationship with respect to peak area in the concentration 100-500ng per spot for both LF and DP with (r² = 0.9993) and (r² = 0.9985) for LF and DP respectively. Limit of detection (15.51 ng/spot for LF and 23.04 ng/spot for DP), limit of quantication (47.03 ng/spot for LF and 69.83 ng/spot for DP) were found. The proposed HPTLC method has potential applications in determination of lafutidine and domperidone in tablet formulations.

Keywords

Lafutidine, Domperidone, HPTLC, Tablet Formulation.

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V. Kishor Kumar ¹, K. G. Lalitha ²

Affiliations
1 Department of Phytopharmacy and Phytomedicine, J. K. K. Munirajah Medical Research Foundation's Annai J. K. K. Sampoorani Ammal College of Pharmacy, B. Komarapalayam – 638 183, Namakkal District, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai – 625 020, Tamil Nadu, IN

Abstract

Helleborus niger L (HN) is widely used in the treatment of diabetes mellitus in the Indian traditional system of medicine. Therefore, the present study was done to evaluate the antihyperglycemic, antihyperlipidemic and antioxidant activities of ethanol extract of HN ischolar_main (EHN) in streptozotocin (STZ) - nicotinamide (NC) induced diabetic rats. in vitro α-amylase inhibition assay, normoglycemic study and oral glucose tolerance test were carried out in different ischolar_main extracts of HN. Antihyperglycemic effect was assessed in EHN using diabetic rats, which was identified as the most effective extract by initial screening. EHN (50, 100 and 200 mg/kg) and glibenclamide (5 mg/kg) orally administered daily for 28 days and the animal was observed in next 14 days. Fasting blood glucose (FBG) and body weight was determined weekly basis up to 42 days. On the 42nd day, various biochemical parameters were estimated. The three doses of EHN shows significantly decrease (p<0.01) in blood glucose levels. The effect was more pronounced in 200mg/kg (71.53%) than 100mg/kg (67.46%) and 50mg/kg (66.63%). In addition, decreased HbA₁C and improved Hb level were 1 evidenced clearly in diabetic rats. Simultaneously, improvements in serum lipid profile, serum liver profile in diabetic rats were also evidenced clearly. Moreover, body weight and protein levels were increased in diabetic rats. On the other hand antioxidant activity was restored in diabetic rats. Increased glycogen content, glucokinase and decreased glucose - 6 phosphatase, fructose 1, 6 - biphosphatase effects in liver tissues were observed. EHN preserved islet architecture and prevented hypertrophy of β-cells. The EHN is capable of managing hyperglycemia and complications of diabetes in STZ-NC induced diabetic rats. Hence this plant may be considered as one of the potential sources for the isolation of new oral antihyperglycemic agent(s).

Keywords

Antihyperglycemic, Antihyperlipidemic, Antioxidant, Helleborus Niger, Nicotinamide, Streptozotocin.

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Anitha Kumari ¹, K. G. Lalitha ¹, T. Venkatachalam ², P. Kalaiselvi ², M. G. Sethuraman ³

Affiliations
1 Ultra College of Pharmacy, Madurai – 625 020, IN
2 Annai JKK Sampoorani Ammal College of Pharmacy, B. Komarapalayam - 638 183, IN
3 Gandhigram Rural University, Gandhigram – 624 302, IN

Abstract

Pavonia zeylanica Linn. (Family: Malvaceae) commonly known as Sittramutti (Tamil) is an herb distributed in the tropical and sub-tropical regions of the world, and also found abundantly in India. It has considerable reputation as a potent medicament in the treatment of various ailments such as inflammation, fever and toothache. The antiinflammatory effect of the leaves of P. zeylanica, was evaluated using carrageenan induced paw oedema and cotton pellet induced granuloma (chronic) in rat models. The extract was also evaluated by hot plate and acetic acid induced abdominal constriction assay to assess analgesic activity. The alcoholic extract of P. zeylanica (AEPZ) exhibited significant (P < 0.01) anti-inflammatory effect at the dose 50, 100 and 200 mg/kg. Maximum inhibition 46.16 % was noted at the dose of 200 mg/kg after 3 h of drug treatment in carrageenan induced paw oedema, whereas the Indomethacin 10 mg/kg (standard drug) produced 65.38 % of inhibition. In the chronic model (cotton pellet induced granuloma) the AEPZ (200 mg/kg) and standard drug showed decreased formation of granuloma tissue by 40.30 % and 67.20 % (P < 0.01) respectively. The extract also found to possess antinociceptive activity against acetic acidinduced writhing and hot plate reaction in mice. In acetic acid-induced abdominal constriction assay ) the AEPZ (200 mg/kg) and standard drug aspirin showed reduction in abdominal constriction by 47.64% and 62.38% (P < 0.01) respectively.Thus, the present study revealed that the alcoholic extract of P. zeylanica exhibited significant antinociceptive and anti-inflammatory activity in the tested models.

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P. Kalai Selvi ¹, T. Venkatachalam ¹, V. Kishor Kumar ¹, K. G. Lalitha ²

Affiliations
1 Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai-625020, Tamil Nadu, IN

Abstract

A Simple and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of Diacerein in bulk and its pharmaceutical formulations. Chromatographic separation was performed by using column XDB C₈ (4.6×150 mm, 5 μm) with a mobile phase comprising of a mixture of phosphate buffer and Acetonitrile (50:50,v/v) and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 0.8 ml/min with detection at 254 nm. Separation was completed in less than 10 min. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, ruggedness and robustness. Linearity of Diacerein was found to be in the range of 10-100 μg/ml and correlation coefficient was found to be 0.999. The retention time of Diacerein was 3.3 min;the separation was performed at an ambient temperature. The limit of Detection and limit of quantitation for Diacerein was found to be 3.6 and 9.95 (S/N ratio). There was no significant difference in the intraday and inter day analysis of Diacerein determined for five different concentrations using this method. The RSD value 0.3% indicates a high precision of the analytical method.

Keywords

The Proposed Method was Simple, Sensitive, Precise, Accurate and Useful for Routine Quality Control Analysis.

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T. Venkatachalam ¹, V. Kishor Kumar ¹, P. Kalai Selvi ¹, R. Srinivasan ¹, R. Mariammal ², K. G. Lalitha ³

Affiliations
1 JKKMMRF College of Pharmacy, B. Komarapalayam, IN
2 ROVER College of Pharmacy, Perambalur, IN
3 ULTRA College of Pharmacy, Madurai, IN

Abstract

Simple, sensitive, and specific spectrophotometric methods were developed and validated for quantitation of Metoprolol succinate and Hydrochlorthiazide in tablet dosage form. A new analytical method was developed based on the simultaneous estimation of drugs in a binary mixture without previous separation. In simultaneous equation method, Metoprolol succinate and Hydrochlorthiazide were determined by using their absorptivity values at wavelength maxima, viz., 222 nm and 272 nm. The standard deviation value for the different validation parameters was found to be between 0.094 and 1.01 for simultaneous equation method. This method is simple, accurate, rapid, and they require no preliminary separation and can therefore be used for routine analysis of both drugs in quality control laboratories.

Keywords

Spectrophotometric, Metoprolol Succinate, Hydrochlorthiazide, Simultaneous Equation Method.

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