Development and validation of new analytical method for the simultaneous estimation of ibuprofen and diphenhydramine in bulk and pharmaceutical dosage form by RP-HPLC

Recent study was conducted to develop and validate analytical methods for estimation of Risedronate sodium in pure and pharmaceutical dosage form using UV Spectroscopy and RP- HPLC method. The first method (Method A) based on the UV Spectroscopy using 0.1M Hcl as diluent lambda max was found at 261 nm. Linearity existed perceived in the concentration between 10-50 μg/ml (r 2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The second method (Method B), based on determination of Risedronate sodium tablet dosage form by RP-HPLC method. Chromatography separation was carried out on a C18 (150X4.6 mm x5 µ) SS Column using Methanol: Ammonium formate (85:15) as the mobile phase at a flow rate of 1.0 ml/min. The chromatographic analysis was carried out in the reflectance and absorbance mode at 254 nm and retention time of the drug was found to be 1.11 ml/min for standard and tablet. Linear responses of the drug were in the concentration range of 200-1000 µg/ml. The accuracy of the method was assessed by standard dilution method and found to be 98% to 102% .The results of the analysis were validated statistically prism software. The method established was found to be simple, precise, linear, accurate and sensitive. The developed method can be used for routine quality control analysis of Risedronate sodium in pure and pharmaceutical dosage form.

Download Full-text

Development and Validation of RP-HPLC method for Simultaneous Estimation of Metformin and Pioglitazone

Indian Journal of Pharmaceutical and Biological Research ◽

10.30750/ijpbr.5.1.7 ◽

2017 ◽

Vol 5 (01) ◽

pp. 48-50

Author(s):

Uttam Kumar Agrawal ◽

Jeyabalan Govindasamy

Keyword(s):

Mobile Phase ◽

Dosage Form ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Simultaneous Estimation ◽

Drug Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Bulk Drug ◽

Development And Validation

A new simple, accurate ,precise and reproducible RP-HPLC method has been developed for simultaneous estimation of metformin and pioglitazone in bulk drug form using proper HPLC system. The mobile phase consists of phosphate buffer and acetonitrile in the ratio of 35:65 at pH 3.4.The detection wavelength was carried out at 228 nm. The method was linear over the concentration range for metformin 50-100 μg/mL and for pioglitazone 20-180 μg/mL. The recoveries of metformin and pioglitazone were found to be 100.5 and 98.7% respectively. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method method was successfully for the analysis of pharmaceutical formulations containing dosage form.

Download Full-text

DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.57.09.11644 ◽

2020 ◽

Vol 57 (09) ◽

pp. 53-59

Author(s):

Girija Dandu ◽

Basu Venkateswara Reddy

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Stability Indicating ◽

Stability Indicating Method ◽

Rp Hplc ◽

Ich Guidelines ◽

Hplc Grade Water ◽

Development And Validation

The present study describes the development and validation of a new stability indicating RP-HPLC method for simultaneous estimation of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase YMC column (4.6 x 250mm, 5μm).The mobile phase used was mixture of HPLC grade water acetonitrile (70:30V/V) at flow rate of 1ml/ min in isocratic mode and detection was carried out using PDA detector at 244nm.The developed method showed a good linearity in the range of 100-500μg/mL for elbasvir and 200-1000 μg/mL for grazoprevir with regression co-efficient of 0.999 for both the drugs. The % recovery of drugs was found to be 100.1% for elbasvir and 100.38% for grazoprevir. The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.

Download Full-text

Simultaneous estimation of gabapentin and methylcobalamin in bulk and pharmaceutical dosage form by RP-HPLC

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v9i1.2204 ◽

2019 ◽

Vol 9 (1) ◽

pp. 170-174

Author(s):

Anjali Bakshi ◽

K Monika ◽

Shweta Bhutada ◽

M. Bhagvan Raju

Keyword(s):

Particle Size ◽

Flow Rate ◽

Retention Time ◽

Mobile Phase ◽

Dosage Form ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Methylcobalamin from bulk and formulation. Chromatographic separation was achieved Isocratically on an Inertsil C18 column (150x4.6, 5µ particle size) using a mobile phase Buffer: Acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, effluents were detected at 264 nm and 10µl of sample was injected. Retention time of Gabapentin & Methylcobalamin was found to be 2.7 and 4.13 min respectively. Linearity of the method was in the concentration range of 25-150 µg for Gabapentin & 0.125-0.750 µg for Methylcobalamin. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision of the method was found to be less than 2%. The method was validated according to the ICH guidelines. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin & Methylcobalamin tablets and was fairly good in comparison with other methods. Keywords: Gabapentin, Methylcobalamin, HPLC.

Download Full-text

Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

10.33974/ijrpst/ ◽

2018 ◽

Vol 1 (1) ◽

pp. 12-21

Keyword(s):

Flow Rate ◽

Dosage Form ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Isocratic Mode

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

Download Full-text

Development and validation of new analytical method for the simultaneous estimation of omeprazole and domperidone in pharmaceutical dosage form by UV spectrophotometry

International Journal of Research In Pharmaceutical Chemistry and Analysis ◽

10.33974/ijrpca.v1i2.63 ◽

2019 ◽

Vol 1 (2) ◽

pp. 44-46

Author(s):

V. Pavan Kumar ◽

C. Bhanu Chandra ◽

N. Devendra ◽

M. Kishor Kumar ◽

S. Reddy Basha ◽

...

Keyword(s):

Dosage Form ◽

Simultaneous Equation ◽

Dosage Forms ◽

Simultaneous Estimation ◽

Uv Spectrophotometry ◽

Pharmaceutical Dosage Form ◽

Pharmaceutical Dosage Forms ◽

Ich Guidelines ◽

Development And Validation

A simple, rapid and precise method was developed for the quantitative simultaneous determination of Omeprazole and Domperidone in combined pharmaceutical-dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 291 nm (λmax of Omeprazole) and 289 nm (λmax of Domperidone) in Methanol: Acetonitrile (30:70 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 µg/ml for Domperidone and 1-50 µg/ml for Omeprazole respectively, with regression 0.999 and 0.999 for Domperidone and Omeprazole respectively. Recovery was in the range of 99 -103%; the value of standard deviation and %R.S.D were found to be < 2 %; shows the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.

Download Full-text

Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

International Journal of Research in Pharmaceutical Sciences and Technology ◽

10.33974/ijrpst.v1i1.19 ◽

2018 ◽

Vol 1 (1) ◽

pp. 12-21

Author(s):

V Pavan Kumar ◽

B Ramadevi ◽

Shaik Karishma ◽

P Divya ◽

B Sivagami ◽

...

Keyword(s):

Flow Rate ◽

Dosage Form ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Isocratic Mode

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

Download Full-text

DEVELOPMENT, VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TENOFOVIR DISPROXIL FUMARATE, EMTRICITABINE AND RILPIVIRINE HYDROCHLORIDE IN BULK, FORMULATION AND USED IN NANOSUSPENSION

INDIAN DRUGS ◽

10.53879/id.56.09.11663 ◽

2019 ◽

Vol 56 (09) ◽

pp. 43-54

Author(s):

K Vijaya Sri ◽

M. Madhuri ◽

V. Anusha ◽

V.R.K. Siresha ◽

Keyword(s):

Research Work ◽

Multicomponent System ◽

Hplc Method ◽

Combination Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Line Of Therapy ◽

Development And Validation

The present research work illustrates the development and validation of RP HPLC method for simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride in bulk and formulated in a pharmaceutical dosage form as a nanosupension. Antiretroviral drug treatment is the primary line of therapy for treating HIV. The multicomponent system formulated as a nanosuspension evidenced increased hydrophilicity, potency and decreased side effects. The separation was carried out by using efficient BDS hypersil C18 HPLC column with empower software. Combination method of Precipitation—ultrasonic homogenization was used for the preparation of the nanosuspension. The mobile phase used was methanol, water, acetonitrile (80:13.4:6.6) v/v and flow rate 1mL /min. The developed method was thus validated as per ICH guidelines for various parameters whose results advocated the reliability of the method. The results for parameters viz. retention times of tenofovir disproxil fumarate, emtricitabine and rilpivirine were 3.09 min, 2.78 min and 3.68 min, linearity range was between 7.5-90, 5-60, 0.625-7.5µg/mL, respectively. Thus the new RP-HPLC method is optimum, reliable and can be used for the simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride.

Download Full-text

Method Development and Validation RP-HPLC Method for the Simultaneous Estimation of Levofloxacin Hemihydrate and Cefpodoxime Proxetil in Gudcef-L Pharmaceutical Dosage Form

Chemical Science Transactions ◽

10.7598/cst2016.1308 ◽

2016 ◽

Keyword(s):

Dosage Form ◽

Method Development ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Cefpodoxime Proxetil ◽

Rp Hplc ◽

Method Development And Validation ◽

Development And Validation

Download Full-text

Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

International Journal of Applied Pharmaceutical Sciences and Research ◽

10.21477/ijapsr.v2i3.8099 ◽

2017 ◽

Vol 2 (03) ◽

pp. 41-45

Author(s):

Sireesha D ◽

Sai Lakshmi E ◽

Sravya E ◽

Vasudha Bakshi

Keyword(s):

High Performance ◽

Dosage Form ◽

Room Temperature ◽

Hplc Method ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Tablet Dosage ◽

Isocratic Mode

A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing methanol, Thermoscientific C18 column, (250x4.6 particle size of 5μ) at room temperature and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ in accordance with ICH guidelines.

Download Full-text